NuMED MULLINS-X Instrucciones De Utilizacion página 4

• Use only appropriate balloon inflation medium. Do not use air or gaseous medium to inflate the balloon.
• 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.
• The catheter should be used prior to the 'Use Before' date noted on the package label.
• Right ventricular outflow tract damage has occurred with balloons larger than 1.5 times the size of valve
annulus.
• THE CATHETER IS NOT INTENDED FOR USE WITH STENTS.
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.
1. Remove balloon protector. Inspect the catheter for damage prior to insertion.
2. Check that all connections are tight. Fill and purge the dilatation balloon. Prime and flush the distal lumen.
3. Prepare a peripheral vein site for catheter insertion. The femoral vein is a recommended site for insertion.
4. Under fluoroscopic guidance advance the guidewire to the desired position. Pass the catheter over the
guidewire. An introducer should be utilized to facilitate catheter insertion.
5. Advance the catheter into the heart and through the valve under fluoroscopic guidance. Place the catheter to
position the mid-length of the balloon within the valve.
6. The distal lumen is provided for guidewire tracking. An inflation device with pressure gauge is required to
monitor inflation pressure [refer to package label for RBP].
7. Perform dilatations using either a 50/50 or a 75/25 solution of saline and contrast medium, respectively.
Patient monitoring is required during dilatations. Balloon can be either partially or fully inflated to achieve
dilatation. DO NOT EXCEED THE RBP.
8. Deflate the balloon by drawing a vacuum with an inflation device with pressure gauge. Note: The greater the
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.
9. Apply pressure to the insertion site according to standard practice or hospital protocol for percutaneous
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
• Arrhythmia Development
• Valvular Tearing or Trauma
• Restenosis Development
• Inflammation
• Infection
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