Potential Complications - NuMED MULLINS-X Gebrauchsanweisung

• Before removing catheter from sheath it is very important that the balloon is completely
deflated.
• Proper functioning of the catheter depends on its integrity. Care should be used when
handling the catheter. Damage may result from kinking, stretching, or forceful wiping of
the catheter.
P C
OTENTIAL OMPLICATIONS
• Potential complications related to the introduction of the catheter into the body include,
but are not limited to, the following: infection, air embolism, and hematoma formation.
• 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.
• Complications associated with PTA include, but are not limited to : clot formation and
embolism, nerve damage, vascular perforation requiring surgical repair, damage to the
vascular intima, cerebral accident, cardiac arrhythmias, myocardial infarction, or death.
For specifics, refer to: Fellows, K. et al.: Acute Complications of Catheter therapy for
Congenital Heart Disease, Amer Journ of Cardiol, 60;679(1987).
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.
I
NSPECTION AND
1. Insert guidewire through the distal tip until guidewire exceeds proximal port.
2. Remove balloon protector. Inspect the catheter for damage prior to insertion.
3. Perform dilatations using either a 50/50 or a 75/25 solution of saline and contrast medium,
respectively.
4. Attach an inflation device with pressure gauge half filled with the contrast solution to the
balloon port of the catheter.
5. Purge the catheter through lumen thoroughly, observing for leaks.
6. To check inflation/deflation times, use a stopwatch. Repeat the procedure several times to
verify the inflation / deflation time.
7. Point inflation device with pressure gauge nozzle downward, aspirate until all air is removed
from the balloon, and bubbles no longer appear in the contrast solution.
8. Turn the stopcock off to maintain the vacuum in the balloon.
9. Remove guidewire.
I : V
NSERTION ASCULAR
1. Enter the vessel percutaneously using the standard Seldinger technique over the appropriate
guidewire for the size catheter being used.
2. Advance the catheter across the lesion with fluoroscopic guidance using accepted
percutaneous transluminal angioplasty technique (see references). In most patients, the
balloon should meet with minimal resistance to insertion. Do not advance the catheter
unless the guidewire is in place.
3. Referring to the balloon-sizing chart, inflate the balloon with contrast medium until the
desired diameter is achieved or the RBP is reached, whichever comes first. DO NOT
EXCEED THE RBP.
D
EFLATION AND
1. 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.
2. 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
P
REPARATION
W
ITHDRAWAL
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