How Supplied; Contraindications; Instructions For Use - NuMED Z-MED II Mode D'emploi

ENGLISH
I
NDICATIONS: Recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the
pulmonary valve.
• A patient with isolated pulmonary stenosis.
• A patient with valvular pulmonary stenosis with other minor congenital heart disease
that does not require surgical intervention.
D
ESCRIPTION
The NuMED PTV Catheter is a coaxial design catheter with a balloon mounted on its distal
tip. The lumen labeled with the balloon size is for balloon inflation while the through lumen
allows the catheter to track over a guidewire. A radiopaque band[s] defines the center [or
shoulders, if two] of the dilatation balloon.
Each balloon inflates to the stated diameter and length at a specific pressure. The balloon
size is ± 10% at the nominal pressure. The Rated Burst Pressure (RBP) is different for each
size. Check the package label for the RBP. It is important that the balloon not be inflated
beyond the RBP.
H S
OW UPPLIED
Supplied sterilized by ethylene oxide gas. Sterile and non-pyrogenic if package is unopened
or undamaged. Do not use the product if there is doubt as to whether the product is sterile.
Avoid extended exposure to light. Upon removal from package, inspect the product to
ensure no damage has occurred.
C
ONTRAINDICATIONS
Other than standard risks associated with insertion of a cardiovascular catheter, there are no
known contraindications for valvuloplasty. The patient's medical condition could affect
successful use of this catheter.
• Patients with mild valvular stenosis.
• A patient with valvular stenosis with major congenital heart defects that require open
heart surgery.
W
ARNINGS
• CAUTION: Do not exceed the RBP. An inflation device with pressure gauge is
recommended to monitor pressure. Pressure in excess of the RBP can cause balloon rupture
and potential inability to withdraw the catheter through the introducer sheath.
• Catheter balloon inflation diameter must be carefully considered in selecting a particular size
for any patient. The inflated balloon diameter should not be significantly greater than valvular
diameter. The choice of the balloon size to be used for valve stenosis has been established
by the VACA Registry to be approximately 1.2 to 1.4 times the valve annulus. It is important
to perform an angiogram prior to valvuloplasty to measure the size of the valve in the lateral
projection.
• Balloons > 4cm in length may impinge upon the tricuspid valve mechanism and may injure it.
Balloons longer than 4cm are not recommended for children < 10 years old.
• Use only appropriate balloon inflation medium. Do not use air or gaseous medium to inflate
the balloon.
• This catheter is not recommended for pressure measurement or fluid injection.
• Do not remove the guidewire from the catheter at any time during the procedure.
• This device is intended for single use only. Do not resterilize and/or reuse it, as this can
potentially result in compromised device performance and increased risk of cross-
contamination.
• The catheter should be used prior to the 'Use Before' date noted on the package label.
• Right ventricular outflow tract damage has occurred with balloons larger than 1.5 times the
size of valve annulus.
• The catheter is intended for valvuloplasty applications only, and is not intended for
angioplasty.
• THE CATHETER IS NOT INTENDED FOR USE WITH STENTS.

Instructions for Use:

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