NuMED COEfficient Instrucciones De Utilizacion página 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 guidance advance the guidewire to the desired position. Pass the catheter over the
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guidewire. An introducer should be utilized to facilitate catheter insertion.
Advance the catheter into the heart and through the valve under fluoroscopic guidance. Place the catheter
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to position the 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
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monitor inflation 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.
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Patient monitoring is 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
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vacuum applied 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 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
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vascular procedures.
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 and related adverse effects associated with the valvuloplasty catheter use include, but are
not limited to:
• Perforation
• Conduction System Injury
• Thromboembolic Events
• Hematoma
• Cardiovascular Injury
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.
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.
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Warranty and Limitations
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Arrhythmia Development
Valvular Tearing or Trauma
Restenosis Development
Inflammation
Infection