Potential Complications - NuMED BIB Instrucciones De Utilizacion

• Careful attention must be paid to the maintenance of tight catheter connections by aspiration
before proceeding to avoid air introduction into the system.
• Under no circumstances should any portion of the catheter system be advanced against
resistance. The cause of the resistance should be identified with fluoroscopy and action
taken to remedy the problem.
• If resistance is felt upon removal, then the balloon, guidewire and the sheath should be
removed together as a unit, 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.
• Before removing the catheter from the 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. Using proper sterile technique, open the catheter package and remove BIB
Inspect the catheter for kinks prior to use. DO NOT REMOVE BALLOON PROTECTOR
FROM BALLOON. The catheter lumen (green hub), the inner balloon (indigo hub), and the
outer balloon (orange hub) are appropriately labeled. Flush catheter lumen (green hub) with
heparinized flush and insert .035 guidewire. DO NOT ATTEMPT TO PURGE BALLOONS
WITHOUT A GUIDEWIRE THROUGH THE CATHETER LUMEN.
2. Prepare an inflation solution of 40% by volume of contrast medium (such as Renografin
76%, Omnipaque
3. Fill and purge air from the inflation devices (2 needed for BIB
handle to "off" position relative to inflation device. Apply negative pressure with the inflation
device and tip to remove air from manometer. Repeat as necessary. Attach one inflation
device to each inflation port of the BIB
adapter. The indigo hub is the smaller inner balloon, the orange hub is the larger outer
balloon.
4. Purging of the two balloons is done with negative pressure only. DO NOT INFLATE EITHER
BALLOON PRIOR TO USE.
5. Attach a syringe capable of maintaining negative pressure (e.g. VacLok Syringe
Medical or Becton-Dickinson
stopcock handle in the "off" position to the syringe, apply negative pressure to the syringe
and lock. ALWAYS START WITH THE INNER BALLOON (INDIGO HUB). Turn the handle
of the stopcock to apply negative pressure to the balloon. Tap the catheter shaft to facilitate
movement of bubbles, and then shut off the negative pressure. Some contrast will passively
move from inflation device into the balloon. Repeat, alternating negative pressure and
P
REPARATION
®
300 etc.) and flush solution.
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luer lock Syringe) to the other port of the stopcock. With the
®
catheter using a three way stopcock with rotating
3
®
catheter.
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catheter). Rotate stopcock
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from Merit
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