How Supplied; Potential Complications; Instructions For Use - NuMED DH Instrucciones De Utilizacion

ENGLISH
INDICATIONS: Recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal
arteries. These catheters are not designed to be used in the coronary arteries.
DESCRIPTION
The NuMED PTA Ultra High Pressure Dilatation 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 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.
• 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- contamination.
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.

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.
• Complications associated with PTA include, but are not limited to: clot formation and embolism, nerve
damage, vascular perforation requiring surgical repair, damage to the vascular intima, cerebral accident,
cardiac arrhythmias, myocardial infarction, or death. For specifics, refer to: Fellows, K. et al.: Acute
Complications of Catheter therapy for Congenital Heart Disease, Amer Journ of Cardiol, 60;679(1987).
NOTE: There have been infrequent reports of larger diameter balloons bursting circumferentially, possibly due to
a combination of tight focal strictures in large vessels. In any instance of a balloon rupture while in use, it is
recommended that a sheath be placed over the ruptured balloon prior to withdrawal through the entry site. This
can be accomplished by cutting off the proximal end of the catheter and slipping an appropriately sized sheath
over the catheter into the entry site. For specific technique, refer to: Tegtmeyer, Charles J., M.D. & Bezirdijan
Diran R., M.D. "Removing the Stuck, Ruptured Angioplasty Balloon Catheter." Radiology, Volume 139, 231-232,
April 1981.
INSPECTION AND PREPARATION
1. Insert guidewire through the distal tip until guidewire exceeds proximal port.
2. Remove balloon protector. Inspect the catheter for damage prior to insertion.

Instructions for Use

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