External Drainage and Monitoring Catheters with BioGlide® [Neurosurgery Wiki]

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====External Drainage and Monitoring Catheters with BioGlide®====

The Medtronic Neurosurgery EDM Ventricular Catheter with BioGlide, 20 cm, and EDM Ventricular Catheter with BioGlide, 35 cm with
Trocar, each have an interior and exterior hydrophilic surface modification for enhanced lubricity and ease of insertion. They are
fabricated from translucent silicone elastomer tubing with a barium sulfate impregnated stripe to provide radiopacity. Relatively firm tubing is incorporated in the catheter design to provide resistance to catheter kinking and compression. The tip of the catheter is bullet shaped and is filled with radiopaque, tantalum-impregnated silicone elastomer. Black, numeric length markers made of graphiteimpregnated silicone elastomer are positioned on the catheter at points 5, 10, and 15 cm from the proximal tip to enable the surgeon to gauge the depth of penetration of the catheter into the lateral ventricle.
A stainless steel stylet, packaged with each catheter, is designed to facilitate introduction of the catheter into the lateral ventricle.

EDM Ventricular Catheter with BioGlide, 20 cm

A translucent silicone elastomer ventricular catheter with a barium sulfate impregnated stripe and BioGlide, 20 cm in length, with black length markers (at 5, 10, and 15 cm from proximal tip), an angled Luer adapter, and a stainless steel stylet to facilitate placement of the catheter in the lateral ventricle. The angled Luer adapter includes a Luer end-cap to facilitate its closure prior to connection to other drainage or monitoring system components. The catheter comes with an integral female Luer adapter to facilitate hydration.

EDM Ventricular Catheter with BioGlide, 35 cm with Trocar
A translucent silicone elastomer ventricular catheter with a barium sulfate impregnated stripe and BioGlide, 35 cm in length with black length markers (at 5, 10, and 15 cm from proximal tip), an angled Luer adapter, a Luer end-cap, a stainless steel stylet, and a stainless steel trocar. The catheter comes with an integral female Luer adapter to facilitate hydration.

====Indications====
The EDM Ventricular Catheters with BioGlide are designed for use as the proximal component for cerebrospinal fluid (CSF) drainage
and/or monitoring from the lateral ventricles of the brain.

====Instructions For Use====
CAUTION: MINIMIZE HANDLING OF BIOGLIDE COMPONENTS PRIOR TO FULL HYDRATION. EXCESSIVE HANDLING MAY CAUSE
DAMAGE TO THE SURFACE HYDROGEL.

Catheter Hydration

Prior to handling, connection, and placement, the EDM Ventricular Catheters with BioGlide must be fully hydrated in sterile, filtered, isotonic saline. 

During submersion, a portion of the hydrating solution is absorbed giving hydrophilic qualities to the surface. An ordinary
silicone elastomer catheter has hydrophobic characteristics (Fig. 1). The hydrophilic qualities of BioGlide Catheters—lubricity and
smoothness—are shown in Figure 2. Full hydration is accomplished in a minimum of two minutes. BioGlide Catheters are packaged in
trays with a built-in well to accommodate the hydrating solution and a channel for catheter submersion.

CAUTION: CATHETER MUST BE FULLY HYDRATED PRIOR TO
REMOVAL FROM TRAY, INSERTION OF STYLET, AND ALL OTHER
HANDLING OPERATIONS. HANDLING WITHOUT FULL HYDRATION
COULD DAMAGE THE CATHETER’S HYDROGEL SURFACE.
CAUTION: DO NOT INSERT STYLET INTO CATHETER LUMEN PRIOR TO
FULL HYDRATION.

BioGlide products are provided sterile, in a double layer packaging system. Using appropriate technique, clean, and then open the outer pouch, allowing the sealed inner tray to fall onto the sterile field. All hydration and handling of the BioGlide products must occur within the sterile field.

CAUTION: LOW
TEAR STRENGTH IS
A CHARACTERISTIC
OF MOST
UNREINFORCED
SILICONE
ELASTOMER
MATERIALS.
CARE MUST BE
TAKEN WITH THE
HANDLING AND
PLACEMENT OF
THE SILICONE
ELASTOMER
CATHETER TUBING
TO AVOID CUTS,
NICKS, OR TEARS.


NOTE: The color of the EDM Catheters with BioGlide may change due to any coloration of the isotonic saline solution used to hydrate the catheter prior to implantation.

NOTE: The BioGlide hydrogel layer may be subject to wear over time, which could expose the silicone elastomer beneath it. The product surface thus exposed would not have the enhanced BioGlide properties, i.e., a hydrophilic surface and enhanced lubricity.

CAUTION: USE OF SHARP INSTRUMENTS DURING HYDRATION OR HANDLING CAN DAMAGE THE SURFACE HYDROGEL OR CAN
NICK, CRUSH, OR CUT THE SILICONE ELASTOMER CATHETER, RESULTING IN LEAKAGE AND NECESSITATING CATHETER REVISION.

Hydration Method

EDM Ventricular Catheters with BioGlide
CAUTION: DO NOT USE ANY CONTAINER OTHER THAN THE BIOGLIDE PACKAGING TRAY TO HYDRATE OR SOAK BIOGLIDE
PRODUCTS. OTHER CONTAINERS MAY CONTAIN SOLUBLE RESIDUES, WHICH MAY BE TAKEN UP BY THE BIOGLIDE LAYER. THIS
MAY RESULT IN ADVERSE PATIENT REACTIONS TO THE IMPLANT.

1. Peel back the lid from the catheter tray.

2. Attach a 60 mL, saline-filled syringe to the integral female Luer adapter.

3. Inject sterile, filtered, isotonic saline into the catheter using a 60 mL syringe.

4. Fill entire lumen of catheter with saline. Continue injecting fluid into the catheter until saline exits the catheter, and the entire catheter becomes immersed in saline.

5. Remove syringe.

6. The catheter may be gently removed from the tray after a minimum hydration period of two minutes.

====Surgical Technique====
Placing the 20 cm EDM Ventricular Catheter with BioGlide

After the 20cm catheter has been hydrated, it can be placed into the intraventricular space using the stylet (the stylet may be placed through the integral female Luer adapter). Remove the integral Luer adapter by trimming the catheter. With gloved hands, attach the angled Luer adapter.

NOTE: Due to the lubricious nature of the hydrated catheter, the use of latex gloves may facilitate the attachment of the
catheter to the angled Luer adapter.

Placing the 35 cm EDM Ventricular Catheter with BioGlide

After hydrating the 35cm catheter cut the integral Luer adapter off and attach the
35 cm catheter to the trocar. Tunnel to the desired exit site. Trim the trocar off of the
catheter. With gloved hands, attach the angled Luer adapter.
NOTE: Due to the lubricious nature of the hydrated catheter, the use of latex
gloves may facilitate the attachment of the catheter to the angled Luer adapter.
Example of a Surgical Technique
A variety of surgical techniques may be used in placing the catheters into the lateral
ventricle. The site of placement and techniques used are at the discretion of the
surgeon.
Prior to surgery, the balance of the drainage and/or monitoring system should be
completely assembled in operational condition. The preoperative preparation of the
patient is carried out with the standards of care appropriate for an intracranial operation.
A broad-spectrum antibiotic is administered preoperatively and continued during the
24-hour postoperative period.
The head is completely shaved, cleaned and prepared in a manner appropriate for
craniotomy. Using local anesthesia, a 2.5cm parasagittal incision is made just anterior
to the right coronal suture in line with the medial margin of the iris. A self-retaining
retractor is inserted and the skull is exposed by retracting the periosteum.
A twist drill hole directed slightly mesially is made with a 9/64” bit. Under ideal
conditions, the twist drill should penetrate the dura without injuring the underlying
brain. The dura may also be opened with a #11 surgical blade.
With the stylet in place, the tip of the ventricular catheter can be directed from the
twist drill hole in the following ways:
1. toward the inner canthus of the ipsilateral eye;
2. in a plane aligned 2 cm anterior to the external auditory canal in the coronal
plane;
3. toward the bridge of the nose; or
4. toward the inner canthus of the contralateral eye.
If the ipsilateral ventricle is not entered, the physician may choose to attempt insertion of
the ventricular catheter from the opposite side of the patient’s skull. Should this also fail,
the surgeon may consider the alternative of monitoring with a subarachnoid bolt (e.g.,
Richmond Bolt).
The relative markers for the incision site and direction for catheter insertion are
illustrated in Figures 8a-b. If a subarachnoid bolt is to be used, then placing the bolt
in a new twist drill hole—to decrease the possibility of clogging of the subarachnoid
bolt with brain tissue—is recommended.
When the ventricle is entered, the stylet is withdrawn and the catheter is occluded at
the scalp level by pinching with an atraumatic clamp. Only a minimal amount of CSF
should be permitted to escape. This is particularly important if the ICP is not elevated.
CAUTION: OVERDRAINING MAY PREDISPOSE TO VENTRICULAR COLLAPSE, AND
POTENTIALLY SUBSTANTIAL PATIENT INJURY.
5 20 cm EDM Ventricular Catheter
7 Tunnel Catheter Under Skin
6 35 cm EDM Ventricular Catheter
Angled Luer
Adapter
Suture
20 cm EDM Ventricular Catheter
EDM Patient Line
35 cm EDM Ventricular Catheter
Tunnel Catheter Under
Skin
EDM Patient
Line
Angled Luer
Adapter
Suture
3
The distal end of the occluded catheter is now tunneled under the scalp to emerge
through an incision placed posterior to the ventriculostomy incision (Fig. 7).
The EDM Ventricular Catheter, 35 cm, includes a trocar, which may be used to facilitate
this placement. The trocar may be inserted into the distal end of the catheter for
attachment. After desired placement of the catheter, cut the distal end of the catheter
to detach the trocar.
The 20cm EDM Ventricular Catheter does not include a trocar.
The enclosed angled Luer adapter may now be inserted into the catheter and attached to
other components of the drainage and/or monitoring system. Specific details regarding
catheter connection are found in the “Instructions For Use” for the Becker® EDMS and
EDM Kits.
Secure the catheter to the angled Luer adapter with a double suture tie using 0 silk
suture (Fig. 5 and Fig. 6).
Care should be taken to ensure that the catheter and the balance of the drainage and/
or monitoring system is filled and devoid of any air bubbles. If the catheter is properly
placed, a satisfactory waveform should be visible on the monitoring equipment. Minor
adjustments of the ventricular catheter position may be necessary to accomplish this.
After a satisfactory waveform is obtained, the ventriculostomy wound is closed with
interrupted sutures and a full head dressing applied.
Needleless Injection Site—Instructions for Use
1. Swab septum of injection site with antiseptic prior to access.
2. Access Interlink® injection site (identified by a colored ring) with Interlink®
cannula (not supplied).
3. Replace every 24 hours or per institutional protocol.
This product does not contain natural rubber latex.
Precautions
If needle must be used, insert small gauge needle into perimeter of septum.
Do not disconnect administration set, syringe or other component from cannula while cannula is still connected to Interlink injection site.
Single use only. Do not resterilize
How Supplied
The EDM Ventricular Catheters with BioGlide are supplied sterile and non-pyrogenic, in double wrap packages. They are intended
for single (one-time) use only. Do not use if package has been previously opened or damaged. Do not resterilize. Resterilization
can damage the product, potentially leading to patient injury. Medtronic Neurosurgery is not responsible for the performance of any
product that has been resterilized.
EDM Ventricular Catheters with BioGlide are packaged singly, or with a trocar, angled Luer adapter, stainless steel stylet, female Luer
adapter, and Luer end-cap.
Special Order Products
If this “Instructions For Use” accompanies a special order product, there will possibly be differences in the physical characteristics
between the product enclosed and the product description in this product package insert. These differences will not affect the safety or
efficacy of the special order product.
Special order products may be supplied sterile or non-sterile as indicated on the product package label. Non-sterile products must be
cleaned and sterilized prior to use.
Patient Education
It is the physician’s responsibility to educate the patient and/or their representative(s) regarding external drainage and monitoring.
This should include a description of associated complications, and an explanation of potential alternative products and treatments.
Contraindications
Intracranial pressure monitoring with a ventricular or lumbar catheter is contraindicated in patients receiving anticoagulants or who
are known to have a bleeding diathesis. The ventricular catheter is contraindicated if scalp infection is present. A patient undergoing
external drainage and monitoring must be kept under continuous, close supervision. The use of a ventricular or lumbar drainage
catheter is contraindicated where trained personnel are not available to supervise monitoring and drainage on a 24-hour-a-day basis.
Warnings and Precautions
It is the responsibility of the physician to describe and explain the following warnings, precautions and complications to the patient
and/or his representatives prior to proceeding with any surgical procedures.
Failure to appropriately adjust the rate of CSF outflow through the external drainage system may result in potentially serious injury to
the patient.
Lint, fingerprints, talc and other surface contaminants or residues from latex gloves can cause foreign body or allergic reactions.
Improper use of instruments in handling or implanting EDM Catheter products may result in the cutting, slitting, breakage or crushing
of components. Such damage may lead to a loss of system integrity, and necessitate surgical revision or removal of the system.
Patients undergoing external drainage and/or pressure monitoring must be constantly supervised on a 24-hour-a-day basis for signs
and symptoms of overdrainage or underdrainage. Inadequate vigilance or improper drainage system setup can lead to serious injury
to the patient.
Patients must be isolated from external drainage systems, by adjustment of the stopcock, prior to being moved or repositioned. See EDM
Kits or Becker® EDMS “Instructions For Use” booklets for stopcock adjustment instructions. After any movement or repositioning, it is
imperative that the height of the external drainage system is verified for accuracy to the patient’s new position. Failure to ensure correct
positioning of the external drainage system can lead to overdrainage or underdrainage, and potentially serious injury to the patient.
8a
8b
4
Care must be taken to prevent complete or partial catheter pullout during patient movement or repositioning.
Care must be taken to ensure that particulate contaminants are not introduced into components during implantation, testing or
handling. This could result in improper performance of the system.
In securing the ventricular catheter to the angled Luer adapter, the ligature encircling the catheter should be securely, but not too
tightly, fastened lest it eventually cut through the silicone tubing.
Care must be taken in the routing of catheters to prevent kinking and needless abrasion along their course.
When the cerebral ventricles are first punctured during the insertion of the catheter, care should be taken to ensure that as little CSF as
possible is lost.
EDM Catheters with BioGlide should be removed if the patient develops signs of meningeal irritation or if there is suspicion of
contamination or infection in the operative site or anywhere along the subcutaneous device.
Separation of EDM Catheter components due to disconnection or catheter fracture has been reported.
Complications
The major complication associated with ICP monitoring with a ventricular catheter is the risk of infection, particularly meningitis and
ventriculitis. The incidence of these infections can be reduced by care in inserting the ventricular catheter and stabilizing it by passing it
through a subgaleal tunnel before it emerges.
Limiting the duration of monitoring from a single site to less than five days will reduce the infection rate. If monitoring must continue
past five days, it is recommended that a new catheter be inserted at a fresh site, and the entire system be changed.
Inadequate patient monitoring of intracranial pressure and CSF drainage may result in temporary or permanent brain damage.
Frequent punctures of the brain to insert the ventricular catheter can predispose to intracerebral hemorrhage and edema causing a
further rise in ICP, and can result in permanent damage to the cerebral tissue. This can result in a loss of sensory or motor functions of
the patient.
Poor recording of ICP will result if the catheter, patient line or other components of the monitoring system become clogged with blood
clots, brain tissue fragments or fibrinous debris.
In patients with small ventricles, the ventricular walls may collapse around the tip of the catheter resulting in obstruction and
predisposing to tentorial herniation. It is therefore extremely important to avoid excessive release of CSF before or after the catheter is
attached to the drainage system.
Returned Goods Policy
Products must be returned in unopened packages, with manufacturer’s seals intact, to be accepted for replacement or credit, unless
returned due to a complaint of product defect or mislabeling.
Determination of a product defect or mislabeling will be made by Medtronic Neurosurgery, which determination will be final.
Products will not be accepted for replacement or credit if they have been in possession of the customer for more than 90 days.

Warranty
A. Standard Limited Warranty. Medtronic Neurosurgery warrants to the original end user purchaser (“Purchaser”) that the enclosed
single use product (“Product”) purchased by Purchaser, at the time of delivery to Purchaser, shall be substantially free from defects in
material and workmanship. Medtronic Neurosurgery makes no warranty (express, implied or statutory) for Products that are modified
(except as expressly contemplated herein) or subjected to unusual physical stress, misuse, improper operation, neglect, improper
testing, use in combination with other products or components other than those for which the Products were designed, or use in any
manner or medical procedure for which the Products are not indicated.




====Recall====
Medtronic, Inc. (NYSE: MDT) announced that the U.S. Food and Drug Administration (FDA) classified as Class I its voluntary recall action initiated on February 11, 2009 of its BioGlide® Ventricular Snap Shunt Catheter (Cat. #s 27782, 27708 and 27802) – the cerebral ventricular catheter component of a shunt for the treatment of hydrocephalus.  FDA defines Class I recalls as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”  This recall action (applicable to units in the United States, Ireland and Australia) involved the retrieval of unused product and safety notification of implanted product of these three catalog numbers of Medtronic Cerebral Ventricular Catheters. Approximately 3,000 catheters have been distributed between 2002 and 2009.  It is estimated that there are 300 unused catheters.

As of March 18, 2009, Medtronic completed contact with all users of these catheters.  This was completed by visit from its field personnel delivering the recall notification and to retrieve unused products.  In addition, Medtronic has notified all its U.S. customers even though they may not have received the affected product.  Patients with the implanted shunt system not experiencing symptoms of shunt malfunction should continue to be managed under the standard patient management protocols.  If a disconnection occurs, patients may present with a return of the symptoms of hydrocephalus and should be assessed in accordance with standard of care for assessment of shunt malfunction.  

The recall involved the following models:
- Innervision Snap Shunt Ventricular Catheter, BioGlide®, Catalog Number 27782
- Snap Shunt Ventricular Catheter, BioGlide®, Catalog Number 27802
- Snap Shunt Ventricular Catheter, BioGlide®, Catalog Number 27708

It has been determined from nine reports of disconnected catheters requiring revision surgery, that the listed ventricular catheters may become detached from the snap base assembly after implantation and that this condition may increase the need for emergency revision surgery.  There have been no reports of patient death or permanent serious injury as a result of this issue. 

Consequences for a patient with failure of a ventricular catheter may include: nausea, vomiting, headache, lethargy, change in mental status, seizures, visual disturbance, and other more serious conditions.  

====Case series====
===2016===
A retrospective study compared the occurrence of [[cerebrospinal fluid infection]] related to use of either standard silastic catheters or [[hydrogel coated catheter]]s ([[Bioglide]], [[Medtronic]]). The enrolment was available to neurosurgery patients undergoing [[shunt surgery]] from October 2012 to 2015 in two centers. 

The follow-up period was more than months.A total of 78 patients were included in the study. In 33 patients 35-cm hydrogel-coated [[ventriculoperitoneal shunt]]s (VPS) were used, and in remaining 45 patients 35-cm standard silastic VPS catheters were used. 

[[Infection]] occurred in 14 (17.9%) patients, including definite VPS-related CSF infection in 6 patients (7.7%) and probable infection in remaining 8 patients (10.3%). There was a significant difference found in patients with total infection between the two groups [RR (95% CI); 0.200 (0.050-0.803), P = 0.014]. Analysis of Kaplan-Meier curve estimates indicated significant statistical difference between the two catheter types in duration (log rank = 4.204, P < 0.05). Significant statistical differences were also found in the subgroups including previous CSF infection within 1 month (log rank = 4.391, P = 0.04), conversion of external ventricular drains to shunt (Log Rank = 4.520, P = 0.03), and hospital stay >1 month (log rank = 5.252, P = 0.02). There was no difference found between the two groups of the patients with other infections within 1 month. The follow-up period was of 36 months.The [[hydrogel coated catheter]] is a safe and related to lower infection rates for high-risk patients who underwent shunt surgery
((Xu H, Huang Y, Jiao W, Sun W, Li R, Li J, Lei T. Hydrogel-coated ventricular
catheters for high-risk patients receiving ventricular peritoneum shunt. Medicine
(Baltimore). 2016 Jul;95(29):e4252. PubMed PMID: 27442653.)).

===2004===
A prospective randomized clinical trial compared the occurrence of CSF infection related to use of either standard silastic or hydrogel coated EVD catheters (Bioglide, Medtronic). Enrolment was available to all adult neurosurgery patients undergoing placement of a first EVD, at three university centers. The catheters were presoaked in a low concentration of bacitracin solution for 5-10 minutes prior to insertion. Bacterial infection was defined by heavy growth in a single CSF sample or light/medium growth in two consecutive samples. A secondary analysis was also conducted for "probable" CSF infection, including patients started on antibiotics after light/medium growth in a single CSF sample. Statistical analyses included Kaplan-Meier survival curve estimates accompanied by Log Rank and Breslow tests.

There were 158 randomized patients available to assess for EVD related infection of CSF. The two study groups had similar clinical characteristics including average duration of EVD use (8 +/- 4 days). Definite CSF infection occurred in seven and probable infection in another six (8% total). Infection incidence rose steadily from day 2 (1%) to day 11 (11%). There was no difference of daily occurrence of EVD infection between the two catheter types.

Infection remains a common hazard in the use of EVD, and we found no reduction of infection using the hydrogel-coated catheters when presoaked in low concentration bacitracin solution
((Kaufmann AM, Lye T, Redekop G, Brevner A, Hamilton M, Kozey M, Easton D.
Infection rates in standard vs. hydrogel coated ventricular catheters. Can J
Neurol Sci. 2004 Nov;31(4):506-10. PubMed PMID: 15595257.
)).