How Supplied; Instructions For Use - NuMED PTS-X Série Mode D'emploi

ENGLISH
INDICATIONS: Recommended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is
important to select the appropriately sized occluder device.
DESCRIPTION
The NuMED PTS-X Sizing Balloon 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. This lu men has two
radiopaque platinum marker bands under the balloon shoulders and there are two additional radiopaque platinum marker bands
spaced at 10 mm (as measured from leading edge to leading edge). These bands are located at the balloon center and are used a s
a distance reference (the 1cm balloon lengths have only two radiopaque marker bands under the balloon shoulders). 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 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.
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.
• Use only appropriate balloon inflation medium. Do not use air or gaseous medium to inflate the balloon.
• Do not advance the guidewire, balloon dilatation catheter, or any other component if resistance is met, without first determining
the cause and taking remedial action.
• 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.
PRECAUTIONS
• One should always select a PTS-X diameter larger than the unstretched defect diameter, i.e., TEE ASD size 12 mm – select 20 or
25 mm PTS-X.
• Caution should be used when inflating the balloon, over inflation can cause trauma and overstretching of the septum.
• Sizing procedures should be conducted under fluoroscopic 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 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, particu larly 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 catheter from sheath it is very important that the balloon is completely deflated.
• Proper functioning of the catheter depends on its integrity. Care should be used when handling the catheter. Damage may result
from kinking, stretching, or forceful wiping of the catheter.

Instructions for Use

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