NuMED Z-MED II Mode D'emploi page 4

P C
OTENTIAL OMPLICATIONS
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
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."
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
W :
ARNING
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.
/A
DVERSE
Warranty and Limitations
4
E
FFECTS
Radiology
, Volume 139, 231-232, April 1981.
•
Arrhythmia Development
•
Valvular Tearing or Trauma
•
Restenosis Development
•
Inflammation
•
Infection
any
instance of a balloon