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

ENGLISH
INDICATIONS
Indicated for stent placement in vessels over 8mm in diameter.
DESCRIPTION
®
The NuMED BIB (Balloon in Balloon) Catheter is a triaxial design catheter. Two lumens are used to inflate the
balloons while one lumen is for tracking over a guidewire. The radiopaque platinum marker(s) are placed
beneath the 'working area' of the balloon. The inner balloon is ½ of the outer balloon diameter and 1 cm shorter.
Each balloon inflates to the stated diameter and length at a specific pressure. The balloon size is ±10% at 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.
The purpose of the double balloon catheter is to apply an incremental inflation for the purpose of opening a
vascular channel using a balloon expandable intravascular stent. The inner balloon provides initial expansion of
the stent and also acts as a tool to hold the stent in place while the outer balloon is inflated. The outer balloon is
then inflated securing the stent against the vessel wall.

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.
WARNING
• 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.
• Confirm that the distal end of the introducing sheath is at least 2.5cm back from the most proximal image
markers before inflating the outer balloon. Failure to do so may stretch the outer tubing and severely hinder
balloon deflation.
• Use two appropriate size inflation devices with pressure gauges for inflation.
• 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.
• When the stent is crimped onto a balloon delivery catheter, the maximum balloon inflation pressure must not
exceed the recommended inflation pressure specified in the manufacturer's instructions.
• 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 except when the procedure
has been completed.
• 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
• The BIB Stent Placement balloon catheter was tested with the NuMED Cheatham Platinum (CP) Stent (bare
& covered)
• Dilatation procedures should be conducted under fluoroscopic guidance with appropriate x-ray equipment.
• Stents are delicate devices. 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 by aspiration before
proceeding to avoid air introduction into the system.
• The inflation diameter of the balloon used during stent delivery should approximate the diameter of the
obstructive vessel and the intended implant site.
• 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, 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 on its integrity. Care should be used when handling the catheter.
Damage may result from kinking, stretching, or forceful wiping of the catheter.
POTENTIAL COMPLICATIONS/ADVERSE EFFECTS
NOTE: Circumferential tear of the delivery balloon catheter prior to complete expansion of the stent may cause
the balloon to become tethered to the stent, requiring surgical removal. In case of rupture of an adequately sized
balloon after stent expansion, it can be withdrawn and a new balloon catheter exchanged over a guidewire to
complete expansion of the stent.
Cardiac catheterization carries certain risks. In addition, potential complications and related adverse effects
associated with stent placement include, but are not limited to:

Instructions for Use

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