How Supplied - Integra CONTOUR-FLEX Instrucciones De Uso

PRECAUTIONS
•
Patients or their representatives should be informed of the warnings and potential complications associated with
use of this device prior to implantation.
• Avoid cutting or occluding catheter tubing when securing tubing to valve connector with ligatures. Do not kink
catheters at any point. Other than trimming catheters or valve tubing, modifications are not recommended.
• Avoid use of sharp metal instruments when handling silicone components to avoid any damage.
• If a hypodermic injection into the reservoir is required, use a 25-gauge or smaller beveled needle and only inject into
the reservoir dome.
• Have duplicates of each component available during implantation.
• Do not lubricate valves. They will be lubricated adequately by the CSF.
• Avoid contaminants such as glove talc and contact with skin oils when handling tubing.
• Do not place the Contour-Flex Valve under the skin of the neck, chest or abdomen.

HOW SUPPLIED

Integra NeuroSciences Contour-Flex valve and shunt systems are supplied sterile and non-pyrogenic in a double-wrap
packaging.
This product is for single use only. Do not reuse. This product is sterilized with ethylene oxide. Do not use if the package
is open or damaged. Use the device prior to the "Use by" date on the package label.
Caution - Do not resterilize. Integra NeuroSciences will not be liable for any direct, indirect, incidental,
consequential or punitive damages resulting from or related to resterilization.
COMPLICATIONS
Complications associated with use of this device may be similar to those associated with medication and anesthetic
methods used in other surgical procedures, as well as the patient's degree of reaction or sensitivity to any foreign object
implanted in the body.
Common complications associated with the shunt system itself may include shunt obstruction, infection, mechanical
failure of system components, and excessive lowering of intracranial pressure.
Kinking of the catheters may cause mechanical failure and result in obstruction of the shunt system. Shunt obstructions in
the Ventricular Catheter are commonly caused by particulate matter, blood clots, fibrin, tumor cell aggregates, etc. The
Ventricular Catheter may become obstructed by being bound by choroid plexus, embedded within the brain, or by
coaptation of ventricular walls. Shunt obstructions in the Distal Catheter are commonly caused by particulate matter,
blood clots, debris, tumor cell aggregates within the lumen, adhesions surrounding slit openings at the tip, bacterial
colonization, or withdrawal of catheter from the atrium or peritoneal cavity due to the growth of the infant or child.
Placement of the Distal Catheter into the peritoneal cavity may result in obstruction due to intraluminal debris,
investment in the greater omentum or bowel, or perforation of surrounding tissues.
Growth of the infant or child may result in Distal Catheter withdrawal from the atrium into the jugular vein or from the
peritoneal cavity into tissue planes where fluid cannot be easily absorbed.
Local or systemic infection is a common and serious adverse effect of shunt implantation, and is primarily caused by skin
contaminations at the surgical wound site. However, infections can also be caused by pathogens circulating in the
bloodstream and/or skin lesions arising from irritation and breakdown of skin over the implanted shunt. Ventriculoatrial
shunting may predispose the spread of bacteria to other areas of the body including vital organs.
Mechanical failure of the shunt system may occur if any components become disengaged or fractured. This may also
result in migration of shunt components into the peritoneal cavity, the right atrium, lateral ventricle of the brain, or
surrounding areas.
Placement of the distal catheter into the right atrium of the heart may lead to embolization of the pulmonary arterial tree
with resulting corpulmonale and pulmonary hypertension.
The incidence of epilepsy has been reported with the use of hydrocephalus shunt systems. Also, the incidence of seizures
has increased with multiple catheter revisions.
In the infant, excessive reduction of CSF pressure will cause marked depression of the anterior fontanelle. It may also
cause overriding of cranial bones and change communicating into non-communicating hydrocephalus.
6
English