VentriClear

Indications, Safety, and Warnings

• VentriClear™ II External Ventricular Drainage (EVD) Catheter Set
• VentriClear™ I Antibiotic Impregnated EVD Catheter

VentriClear II External Ventricular Drainage (EVD) Catheter Set

Indications

The VentriClear II Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.

The product is intended for use by physicians trained and experienced in neurosurgery. Standard techniques for placement of ventricular catheters should be employed.

Contraindications

This device is contraindicated in patients having allergy or history of allergy to tetracyclines or rifampin. 

NOTE: Because the VentriClear II Ventricular Drainage Catheter is impregnated with a combination of the antimicrobial agents minocycline (a derivative of tetracycline) and rifampin (a derivative of rifampin B), their associated contraindications, warnings and precautions (Physician’s Desk Reference) should be considered when using this device, although there have been no reports of detected systemic levels of minocycline or rifampin in patients receiving a VentriClear II catheter.

Minocycline and rifampin are agents that do not induce any genotoxic risks except a possible teratogenic effect in pregnant women. We therefore do not recommend the use of VentriClear II in pregnant women.

Warnings and Precautions

• This device is not intended for permanent implantation.
• This device should not be used if dermatitis or scalp infection is present at the catheter insertion site.
• Care must be taken when using this device in patients receiving anticoagulants or in those who are known to have bleeding diathesis.
• Patients with ventricular catheters must remain under close observation during the postoperative period for signs and symptoms of increased intracranial pressure that suggest catheter malfunction or obstruction. Increasing intracranial pressure is characterized by headache, vomiting, irritability, listlessness, drowsiness, nuchal rigidity, increased tension of the anterior fontanelle, congestion of scalp veins, and variable abnormal neurological findings. Overdrainage of CSF may predispose development of a subdural hematoma or hydroma, or collapse of the lateral ventricular walls, leading to obstruction of the ventricular catheter.
• Since intracranial pressure is controlled by the height of the drip chamber or collection bag relative to the patient, it is imperative that neither the drip chamber (collection bag) nor the patient be accidentally raised or lowered. The height of the drip chamber (collection bag) or patient should be changed only by qualified personnel or by physician order.
• The ventricular catheter may become obstructed by particulate matter such as blood clots, brain fragments, or other tissue particles, or by excessive reduction of ventricle size.
• Occasionally, fibrous adhesions will bind the catheter to the adjacent choroid plexus or brain tissue. Gentle rotation may free the catheter. Under no circumstances should the catheter be forcefully removed. If the catheter cannot be removed without force, it is advisable to allow it to remain in place, rather than risk intraventricular hemorrhage.
• Development of a hypersensitivity reaction should be followed by removal of the catheter and appropriate treatment at the discretion of the attending physician.
• Aseptic technique is necessary in all phases of use with this product. Routine catheter care protocols should be initiated after implantation.
• Inspect contents of this set for damage. If product is damaged, do not use.
• Refer to the manufacturer’s instructions when using accessory components other than Cook products.
• Prior to procedure, in all but exceptional cases, prospective patients or their representatives should be informed of the possible complications associated with the use of this product.
• Exercise caution when placing and using the catheter to prevent contact with bare fingers, talc, towels, or any lint-bearing surfaces that could contaminate the catheter surface and cause tissue reactions.
• The catheter should not come into contact with ethyl alcohol, isopropyl alcohol, or other alcohols, acetone or other non-polar solvents. These solvents may remove the antimicrobials from the catheter and reduce the catheter’s antimicrobial activity.
• Kinking of catheter tubing may result in restricted flow or damage to the catheter.
• The catheter should be secured with non-metallic sutures in such a manner as to avoid cutting or occluding the tubing. The use of stainless steel ligatures on silicone products is not recommended.
• Use rubbershod forceps when handling the catheter to prevent tearing or cutting the catheter.

VentriClear I Antibiotic Impregnated EVD Catheter

Indications

The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.

The product is intended for use by physicians trained and experienced in neurosurgery. Standard techniques for placement of ventricular catheters should be employed.

Contraindications

This device is contraindicated in patients having allergy or history of allergy to tetracyclines or rifampin. 

NOTE: Because the VentriClear Ventricular Drainage Catheter is impregnated with a combination of the antimicrobial agents minocycline (a derivative of tetracycline) and rifampin (a derivative of rifampin B), their associated contraindications, warnings and precautions (Physician’s Desk Reference) should be considered when using this device, although there have been no reports of detected systemic levels of minocycline or rifampin in patients receiving a VentriClear catheter.

Warnings and Precautions

• This device is not intended for permanent implantation.
• This device should not be used if dermatitis or scalp infection is present at the catheter insertion site.
• Care must be taken when using this device in patients receiving anticoagulants or in those who are known to have bleeding diathesis.
• Patients with ventricular catheters must remain under close observation during the postoperative period for signs and symptoms of increased intracranial pressure that suggest catheter malfunction or obstruction. Increasing intracranial pressure is characterized by headache, vomiting, irritability, listlessness, drowsiness, nuchal rigidity, increased tension of the anterior fontanelle, congestion of scalp veins, and variable abnormal neurological findings. Overdrainage of CSF may predispose development of a subdural hematoma or hydroma, or collapse of the lateral ventricular walls, leading to obstruction of the ventricular catheter.
• Since intracranial pressure is controlled by the height of the drip chamber or collection bag relative to the patient, it is imperative that neither the drip chamber (collection bag) nor the patient be accidentally raised or lowered. The height of the drip chamber (collection bag) or patient should be changed only by qualified personnel or by physician order.
• The ventricular catheter may become obstructed by particulate matter such as blood clots, brain fragments, or other tissue particles, or by excessive reduction of ventricle size.
• Occasionally, fibrous adhesions will bind the catheter to the adjacent choroid plexus or brain tissue. Gentle rotation may free the catheter. Under no circumstances should the catheter be forcefully removed. If the catheter cannot be removed without force, it is advisable to allow it to remain in place, rather than risk intraventricular hemorrhage.
• Development of a hypersensitivity reaction should be followed by removal of the catheter and appropriate treatment at the discretion of the attending physician.
• Aseptic technique is necessary in all phases of use with this product. Routine catheter care protocols should be initiated after implantation.
• Inspect contents of this set for damage. If product is damaged, do not use.
• Refer to the manufacturer’s instructions when using accessory components other than Cook products.
• Prior to procedure, in all but exceptional cases, prospective patients or their representatives should be informed of the possible complications associated with the use of this product.
• Exercise caution when placing and using the catheter to prevent contact with bare fingers, talc, towels, or any lint-bearing surfaces that could contaminate the catheter surface and cause tissue reactions.
• The catheter should not come into contact with ethyl alcohol, isopropyl alcohol, or other alcohols, acetone or other non-polar solvents. These solvents may remove the antimicrobials from the catheter and reduce the catheter’s antimicrobial activity.
• Kinking of catheter tubing may result in restricted flow or damage to the catheter.
• The catheter should be secured with non-metallic sutures in such a manner as to avoid cutting or occluding the tubing. The use of stainless steel ligatures on silicone products is not recommended.
• Use rubbershod forceps when handling the catheter to prevent tearing or cutting the catheter.