How Supplied; Contraindications; Instructions For Use - NuMED TYSHAK Mode D'emploi

ENGLISH
INDICATIONS: 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.
DESCRIPTION
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 Rated Burst Pressure
(RBP). The 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.

HOW SUPPLIED

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.

CONTRAINDICATIONS

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.
WARNINGS
• 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.
PRECAUTIONS
• Dilatation procedure should be conducted under fluoroscopic/MRI guidance with appropriate x-ray equipment.
• Guidewires are delicate instruments. Care should be exercised while handling to help prevent the possibility of breakage.
• Careful attention must be paid to the maintenance of tight catheter connections and aspiration before proceeding to avoid
air introduction into the system.
• Under no circumstances should any portion of the catheter system be advanced against resistance. The cause of the
resistance should be identified with fluoroscopy/MRI and action taken to remedy the problem.
• If resistance is felt upon removal, then the balloon, guidewire, and the sheath should be removed together as a unit,
particularly if balloon rupture or leakage is known or suspected. This may be accomplished by firmly grasping the balloon
catheter and sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction.
• Before removing the catheter from the sheath it is very important that the balloon is completely deflated.
• Proper functioning of the catheter depends upon its integrity. Care should be used when handling the catheter. Damage
may result from kinking, stretching, or forceful wiping of the catheter.
MRI Safety Information
Non-clinical testing has demonstrated that NuMED's Balloon Catheter Systems are MR Conditional. The following labeling is
specific to NuMED's catheters and does not apply to guidewires or other accessories used in combination with NuMED's Balloon
Catheter Systems. Users should consult the instructions for use and MRI safety information of other accessory devices used with
NuMED's catheters. NuMED's Balloon Catheter Systems may be safely scanned anywhere in the body at 1.5T or 3.0T under the
following conditions. Failure to follow these conditions may result in injury.
Parameter
Device Name
Static Magnetic Field Strength (B0)
MR Scanner Type
Maximum Spatial Field Gradient
RF Excitation
RF Transmit Coil Type
Operating Mode
RF Conditions
Scan Duration
Image Artifact

Instructions for Use

Condition
NuMED's Balloon Catheter Systems
1.5T and 3T
Cylindrical
19 T/m (1,900 G/cm)
Circularly Polarized (CP)
Integrated Whole Body Transmit Coil
Normal Operating Mode
Maximum Whole-body SAR: 2.0 W/kg
2 W/kg whole-body average SAR for 60 minutes of continuous RF scanning
The presence of a NuMED Balloon Catheter in combination with an 0.035" MR
Conditional guidewire may produce a radial image artifact of 1.8 cm.
2