NuMED NuCLEUS-X Instrucciones De Utilizacion página 4

11.0 Advance the catheter into the heart and through the valve under fluoroscopic guidance.
Position the catheter so the center image band is located within the valve.
12.0 After correct positioning is confirmed, turn the stopcock to close the vacuum syringe port.
13.0 Inject a small amount of fluid into the balloon. This will inflate the ends of the balloon and
seat the balloon into position in the valve.
14.0 After reconfirming proper positioning, balloon can be either partially or fully inflated to
achieve dilatation. The waist area of the balloon will be at rated size when RBP is reached.
DO NOT EXCEED THE RBP.
15.0 Deflate the balloon by drawing a vacuum on the syringe. 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 resis-
tance is felt upon removal, then the balloon, guidewire and 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.
16.0 Apply pressure to the insertion site according to standard practice or hospital protocol for per-
cutaneous vascular procedures.
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 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 of Vascular or Cardiac Tissue
•
Conduction System Injury
•
Thromboembolic Events
•
Hematoma
•
Cardiovascular Injury
•
Bleeding
•
Balloon Rupture
•
Calcium Embolic Events
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.
/A E
DVERSE FFECTS
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•
Arrhythmia Development
•
Valvular Tearing or Trauma
•
Restenosis Development
•
Inflammation
•
Infection
•
Death
•
Cardiac Tamponade
•
Valvular Regurgitation