NuMED COEfficient Mode D'emploi page 3

INSTRUCTIONS FOR USE
Prior to valvuloplasty, carefully examine all equipment to be used during the procedure, including the catheter, to verify proper function
and that the catheter size is suitable for the specific procedure for which it is intended. Also, inflate the dilatation catheter to the
appropriate RBP and deflate to verify proper function.
Remove balloon protector. Inspect the catheter for damage prior to insertion.
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Check that all connections are tight. Fill and purge the dilatation balloon. Prime and flush the distal lumen.
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Prepare a peripheral vein site for catheter insertion. The femoral vein is a recommended site for insertion.
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Under fluoroscopic/MRI guidance advance the guidewire to the desired position. Pass the catheter over the guidewire. An
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introducer should be utilized to facilitate catheter insertion.
Advance the catheter into the heart and through the valve under fluoroscopic/MRI guidance. Place the catheter to position the
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mid-length of the balloon within the valve. A radiopaque band[s] defines the center [or shoulders, if two] of the dilatation balloon.
The distal lumen is provided for guidewire tracking. An inflation device with pressure gauge is required to monitor inflation
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pressure [refer to package label for RBP].
Perform dilatations using either a 50/50 or a 75/25 solution of saline and contrast medium, respectively. Patient monitoring is
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required during dilatations. Balloon can be either partially or fully inflated to achieve dilatation. DO NOT EXCEED THE RBP.
Deflate the balloon by drawing a vacuum with an inflation device with pressure gauge. Note: The greater the vacuum applied
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and held during withdrawal, the lower the deflated balloon profile. Gently withdraw the catheter. As the balloon exits the vessel,
use a smooth, gentle, steady motion. If resistance is felt upon removal, then the balloon, guidewire and the sheath should be
removed together as a unit under fluoroscopic/MRI guidance, 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.
Apply pressure to the insertion site according to standard practice or hospital protocol for percutaneous vascular procedures.
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Dispose of device after use according to standard hospital protocol for biohazardous devices.
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POTENTIAL COMPLICATIONS/ADVERSE EFFECTS
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.
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.
Potential complications & adverse effects associated with device use and indication include:
• Perforation
• Conduction System Injury
• Thromboembolic Events
• Cardiovascular Injury
• Arrhythmia Development
• Restenosis Development
Any serious incident that has occurred in relation to the device should be reported to NuMED & the Competent Authority in the country of
use.
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, desp ite 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.
Catheters and accessories are sold in an 'as is' condition. The entire risk as to the quality and performance of the catheter is with the
buyer. NuMED disclaims all warranties, expressed or implied, with respect to catheters and accessories, including but not limited to, any
implied warranty of merchantability or fitness for a particular purpose. NuMED shall not be liable to any person for any medical expenses
or any direct or consequential damages resulting from the use of any catheter or accessory or caused by any defect, failure, or
malfunction of any catheter or accessory, whether a claim for such damages is based upon warranty, contract, tort, or otherwise. No
person has any authority to bind NuMED to any representation or warranty with respect to catheters and accessories.
• Inflammation
• Infection
• Cardiac Tamponade
• Valvular Regurgitation
• Access Site Complications
Warranty and Limitations
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