Instructions For Use - NuMED MULLINS-X Instrucciones De Utilizacion

ENGLISH
DESCRIPTION
The NuMED 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.
Four radiopaque bands define the center of the dilatation balloon - two on each side of the balloon center
spaced 10mm apart, and two 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. Please 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.
PRECAUTIONS
• Dilatation 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, 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 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.
WARNING: NuMED catheters are placed in the extremely hostile environment of the human body. Catheters
may fail to function for a variety of causes including, but not limited to, medical complications or failure of
catheters by breakage. In addition, despite the exercise of all due care in design, component selection,
manufacture and testing prior to sale, catheters may be easily damaged before, during, or after insertion by
improper handling or other intervening acts. Consequently, no representation or warranty is made that failure or
cessation of function of catheters will not occur or that the body will not react adversely to the placement of
catheters or that medical complications will not follow the use of catheters.
NuMED cannot warrant or guarantee NuMED accessories because the structure of the accessories may be
damaged by improper handling before or during use. Therefore, no representations or warranties are made
concerning them.
INDICATIONS: Recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal
arteries. This catheter is not indicated for use in the coronary arteries, stent placement or stent redilation.
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.
• In PTA, the dilated balloon should not markedly exceed the diameter of the artery lying just proximal to the
stenosis.
• 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-contamintion.
POTENTIAL COMPLICATIONS
• Potential complications related to the introduction of the catheter into the body include, but are not limited to,
the following: infection, air embolism, and hematoma formation.
• Potential balloon separation following balloon rupture or abuse and the subsequent need to use a snare or
other medical interventional techniques to retrieve the pieces.

Instructions for Use

Instructions for Use (PTA)
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