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Warnings
•
Do not exceed the rated burst pressure. Pressure in excess of the rated burst pressure can
cause balloon rupture, embolization of balloon fragments, and potential inability to withdraw
the catheter.
• If excessive resistance is felt upon removal, or the balloon bursts during inflation, the balloon
and sheath should be removed together as a unit over the guidewire, maintaining vascular
access. Continued guidewire access permits reintroduction of a new introducer sheath to
preserve hemostasis.
• Multiple inflations of the balloon in excess of the rated burst pressure can cause irreversible
enlargement of the waist diameter as a function of pressure.
• Use only appropriate balloon contrast inflation medium, in a 1:8 or higher dilution of contrast
medium to saline. Do not use air or gaseous medium to inflate the balloon.
• This catheter is not intended for pressure measurement or fluid injection.
• The catheter should be used prior to the 'Use Before' date noted on the package label. The
catheter is intended for aortic valvuloplasty applications only, and is not intended for
re-dilatation of stents or stented valves.
• During the procedure, an external defibrillator should always be on hand and ready to use.
• Temporary pacing, or rarely permanent pacing, may be required due to intra-cardiac catheter
or guidewire manipulation, or balloon inflation induced heart block.
• Prolonged inflation of the balloon can cause prolonged hypotension and hypoperfusion of
critical vascular beds resulting in loss of conscious and acute cardiopulmonary arrest.
Duration should be limited to a brisk inflation/deflation cycle. Limit the number of inflations
and correctly size the balloon per Page 8.
• Do not reuse the V8 product as it compromises the intended function or performance or
encourages the spread of infection. The V8 product should be used on one patient for a
single procedure then discarded. It should not be reprocessed and used again, even on the
same patient.
Precautions
• Avoid extended exposure to light and store at room temperature.
• Proper functioning of the catheter depends upon its integrity. Care should be used when
handling the catheter. Damage may result from kinking, stretching, or forceful wiping of the
catheter. Do not use product if contents of package are broken or loose.
• Dilatation procedure should be conducted under fluoroscopic guidance with appropriate x-ray
equipment.
• Careful attention must be paid to the maintenance of tight catheter connections before
proceeding to avoid air introduction into the system.
• Under no circumstances should any portion of the catheter system be advanced against
significant resistance. The cause of the resistance should be identified with fluoroscopy and
action taken to remedy the problem.
1204-001 Revision C.1
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