Adverse Events; Device Description - Codman HAKIM Manual Del Usuario

To better stabilize the position of the valve underneath the scalp, proper
valve placement is required. Place the flat underside of the valve against the
bone, with the round top surface facing upward.
Verify proper placement and integrity of ligatures at all tubing junctions to
prevent obstruction of the catheter lumen and tears or abrasions of the
silicone tubing.
Do not fill, flush, or pump the valve with fluid in which cotton, gauze,
or other lint-releasing material has been soaked.
Exercise extreme care to prevent the silicone components of the system
from coming in contact with bare fingers, towels, drapes, talc, or any linty
or granular surfaces. Silicone rubber is highly electrostatic and, as a result,
attracts airborne particles and surface contaminants that could produce
tissue reaction.
After implantation, avoid unnecessary pumping of the prechamber and
pumping chamber to prevent rapid alteration of the intraventricular pressure.
Cylindrical Valves only: Before closing the scalp incision (or mastoidal
incision, if a two-step passage technique is employed), confirm that the
direction-of-flow arrow on the valve faces up.

Adverse Events

Devices for shunting CSF may have to be replaced at any time due to
medical reasons or failure of the device.
Keep patients with implanted shunt systems under close observation for
symptoms of shunt failure.
Complications of implanted shunt systems include mechanical failure, shunt
pathway obstruction, infection, foreign body (allergic) reaction to implants,
and CSF leakage along the implanted shunt pathway.
Clinical signs such as headache, irritability, vomiting, drowsiness, or
mental deterioration may be signs of a nonfunctioning shunt. Low-grade
colonization, usually with Staph. epidermidis, can cause, after an interval
from a few days to several years, recurrent fevers, anemia, splenomegaly,
and eventually, shunt nephritis or pulmonary hypertension. An infected shunt
system may show redness, tenderness, or erosion along the shunt pathway.
Accumulation of biological matter (i.e. blood, protein accumulations, tissue
fragments, etc.) in the programming mechanism can cause inability of the
device to be reprogrammed.
Clogging of the programmable valve with biological matter can cause the
valve to become unresponsive to attempts to change the pressure setting.
Do not use excessive force if attempting to remove the catheter(s).
Excessive force can cause the catheter to break, leaving part of the catheter
within the body.
Excessive CSF drainage can cause subdural hematomas, slit-like ventricles,
and in infants, sunken fontanelles.
Particulate matter such as blood clots, brain fragments, or other tissue
particles can obstruct the ventricular catheter. Also, the ventricular catheter
can become obstructed by excessive reduction of ventricle size.
If not properly located in the lateral ventricle, the catheter can become
embedded in the ventricular wall or choroid plexus.
Fibrous adhesions can bind the catheter to the adjacent choroids plexus
or to the ventricular wall. Gentle rotation may free the catheter. DO NOT
REMOVE THE CATHETER FORCEFULLY. If the catheter cannot be
removed without force, it is recommended that it remain in place, rather
than risk intraventricular hemorrhage.
The ventricular catheter can be withdrawn from, or lost in, the lateral
ventricles of the brain if it becomes detached from the shunt system.
Blunt or sharp trauma to the head in the region of implant or repetitive
manipulation of the valve during implant may compromise the shunt.
Check valve position and integrity after occurrence.

Device Description

Programmable Valve Operating Pressure
30 to 200 mm H O (294 to 1960 Pa) programmable in steps of
2
10 mm H O (98 Pa)
2
Programmable Valve Configurations
In-line with SIPHONGUARD Device
In-line with SIPHONGUARD Device and Platform with Proximal Tube
In-line
Right Angle with SIPHONGUARD Device
Right Angle
Cylindrical with Prechamber
®
Cylindrical with RICKHAM Reservoir
Cylindrical
Micro with RICKHAM Reservoir
Micro
CODMAN HAKIM In-line and Right Angle Valves include a programmable
valve with a low profile and flat bottom, and an in-line or right angle integral
reservoir with or without SIPHONGUARD.
CODMAN HAKIM Cylindrical Valves include a programmable valve, a
pumping chamber, and an outlet valve available with a prechamber, without
a prechamber, or with a RICKHAM reservoir.
CODMAN HAKIM Micro Valves include a programmable valve with or
without an integral RICKHAM reservoir.
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