How Supplied - Novus NL850-9010 Instrucciones De Uso

NeuroSciences Peritoneal Reflux
Control Catheter (Catalog NL850-1375)
or Peritoneal Open-Ended Catheter
(Catalog No. NL850-1376) with all
pressure ranges of the NOVUS and
NOVUS Mini Valves.

How Supplied

The NOVUS and NOVUS Mini Valves are
supplied in a sterile, pyrogen-free,
double-wrap packaging system. The
double-wrap system facilitates the
preferred method of sterile-product
transfer from the circulating area to the
sterile field. A radiopaque ventricular
catheter guide is provided to help direct
the catheter out of the trephine opening
to minimize kinking.
Do Not Resterilize
This product is for Single Use Only.
Warnings
Hydrocephalic patients with
cerebrospinal fluid drainage systems
must be kept under close observation
for signs and symptoms of increasing
intracranial pressure due to shunt
failure. These signs and symptoms
may vary from patient to patient.
Increasing intracranial pressure is
characterized by headache, vomiting,
irritability, listlessness, drowsiness,
other signs of deterioration of
consciousness, and nuchal rigidity. In
the infant, increased scalp tension at
the anterior fontanelle and congestion
of scalp veins will be noted.
This device is made of silicone rubber,
which like most rubber, may stick to
itself when dry. This tendency to stick
may result in some valve performance
variations which may differ from label
specifications. When wet, the tendency
for silicone rubber to stick is reduced;
therefore, the surgeon must verify that
the valve components are wet and that
fluid flows freely through the valve.
(See Instructions For Use.)
This device has not been tested for
drug compatibility and therefore is not
intended for drug administration.
Integra NeuroSciences makes no
claim for or representation as to the
performance characteristics of this
product if it is used in conjunction
with components of other
manufacturers.
Silicone tubing may be easily cut or
torn when instruments are used to
secure it to a connector. The use of
instruments to attach silicone catheters
to connectors should be avoided. When
instruments are used, carefully inspect
the tubing for nicks or other damage
prior to closure.
Precautions
Prior to surgery, prospective patients or
their representatives should be
informed of the possible complications
associated with the use of this product.
Fluid flow through the flushing valve
should be verified immediately prior to
implantation.
If a hypodermic injection into the
flushing valve is required, use a 25-
gauge or smaller needle and inject
through the reservoir dome only.
The silicone proximal and distal
catheter tubing should be carefully
secured to the connectors with
ligatures in such a manner as to avoid
cutting or occluding the tubing.
Complications
Complications which may result from
the use of this product include the risks
associated with the medication and
methods utilized in the surgical
procedure, as well as the patient's
response, reaction or degree of
intolerance to any foreign object
implanted in the body.
The principal complications associated
with cerebrospinal fluid shunting into
the right atrium or peritoneum are shunt
obstruction, functional failure of the
shunt system, infection or intracranial
hypotension.
Shunt obstruction may occur in either
the proximal ventricular catheter or in
the distal, atrial or peritoneal catheters.
Ventricular catheters may be obstructed
by particulate matter such as blood
clots, fibrin or brain fragments. If not
properly located in the lateral ventricle,
the catheter may become embedded in
the ventricular wall or choroid plexus.
Less commonly, the catheter may be
obstructed by excessive reduction of
ventricular size to slit-like proportions.
Cardiac and peritoneal catheters may
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also be obstructed by particulate matter.
The intra-atrial segment of the cardiac
catheter may be obstructed by
investment in a thrombus. Emboli from
the latter may seed the pulmonary
circulation sufficiently to result in
pulmonary artery hypertension and cor
pulmonale. Peritoneal catheters may be
obstructed by the omentum or coiled
loops of bowel.
Loss of valve and/or reservoir patency
may result from obstruction of the fluid
pathway by particulate matter such as
blood clots or other biological
accumulations.
Functional failure of the shunt system
due to separation of its component
parts can result in serious
complications. Ventricular catheters
may migrate into the lateral ventricles.
Should the cardiac catheter become
detached, it may lodge in the right
atrium or ventricle or, rarely, in the
pulmonary artery. Peritoneal catheters
may migrate completely into the
peritoneal cavity. Volvulus and
perforation of intra-abdominal viscera
may occur or the catheter may be
extruded.
Infection is a common and serious
complication of a shunting system and
is most frequently caused by skin
contaminants. Septicemia, which
occurs most frequently in debilitated
infants, can result from infections
anywhere in the body and may develop
with few or no symptoms. It may occur
as a result of a wound infection. The
presence of a foreign body (i.e. the
shunting system) may trigger
ventriculitis or a dormant meningitis.
Intracranial infection may then be
disseminated throughout the body via
the distal catheter. Lesions developing
from the breakdown of skin or tissue
over the shunting system may also
serve as foci of serious infections. In
the event of an infection, removal of the
shunt system is indicated in addition to
the appropriate therapy.
Excessive lowering of intracranial
pressure may result in complications,
particularly in the infant. These include
subdural hematomas, markedly sunken
fontanelles, overriding of cranial bones
and the conversion of a communicating
to a noncommunicating hydrocephalus
due to obstruction of the aqueduct of
Sylvius.