NuMED BIB Mode D'emploi page 3

• Stent misplacement
• Stent migration
• Minor hematoma
• Intraluminal thrombosis
• Pseudoaneurysm
• AV fistula formation
• Bleeding requiring transfusion
INSPECTION AND PREPARATION
1. Using proper sterile technique, open the catheter package and remove BIB
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
300 etc.) and flush solution.
3. Fill and purge air from the inflation devices (2 needed for BIB
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
using a three way stopcock with rotating 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
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Becton-Dickinson
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 passive
contrast, until you no longer have bubbles when applying negative pressure. It will be necessary to repeat
this process several times. Repeat process with the outer balloon.
6. Leave both balloons on continuous negative pressure for insertion. Remove balloon protector prior to
removing the guidewire. Flush catheter lumen with heparinized flush.
INSTRUCTIONS FOR USE
Prior to stent placement, carefully examine all equipment to be used during the procedure. Verify that the
catheter size is suitable for the specific procedure for which it is intended.
1. Always place an appropriate sized guidewire through the balloon catheter lumen while prepping the balloon
and crimping the stent.
2. Visually inspect the balloon catheter being used to insure that it is properly folded to its lowest profile. "Dry
Prepping" the balloon delivery catheter by using negative pressure is highly recommended.
3. Slide the stent over the distal end of the balloon, maintaining the balloon fold, until the radiopaque markers
are equal distance from the ends of the stent. Check the stent position under the fluoroscope before
crimping.
4. Gently crimp the stent on the balloon by using finger pressure and a "rolling action" to exert equal pressure
on all sides of the stent. Place a small amount of undiluted contrast to "coat" the stent and improve
adherence to the balloon. (AVOID BENDING OR TWISTING THE STENT)
5. Visually inspect the balloon/stent assembly to assure proper placement of the stent (may be confirmed by
fluoroscopy).
6. The assembly is advanced through the long delivery sheath and over the stiff guidewire into the desired
location for implant. Sometimes covering the balloon mounted stent with a protective plastic covering while
introducing through the bleed-back valve of the delivery sheath will decrease the incidence of stent
movement on the BIB
7. After correct positioning of the stent, pull back on the sheath to expose the stent. Confirm proper stent
position by a small injection of contrast through the sidearm of sheath or through a second catheter.
8. Expand the stent initially by inflating the inner balloon by twisting the locked pressure gauge inflation device
until the inner balloon is fully expanded. One may "reposition" the stent at this point by moving the BIB
catheter. The unexpanded outer balloon and expanded inner balloon hold the stent tightly against the BIB
catheter.
9. Confirm positioning and inflate the outer balloon to rated diameter. Do not exceed the manufacturer's balloon
rated burst pressure.
10. Once the stent is expanded, deflate both balloons completely. If there is a residual waist in the stent, expand
only the outer balloon again, making sure not to exceed RBP. Deflate the balloon and rotate the BIB
to insure the stent is free and properly deployed.
11. Remove the balloon catheter and confirm the result with angiography.
NOTE: Diameter of the stent may be increased after placement by expanding with a larger diameter
balloon. Do not exceed the maximum recommended expanded stent diameter.
WARNING: 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
luer lock Syringe) to the other port of the stopcock. With the stopcock handle in the "off"
® catheter during deployment.
• Sepsis/infection
• Distal thromboemboli
• Death
• Vessel rupture
• Cerebrovascular incident
• Hematoma requiring repair
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catheter). Rotate stopcock handle to "off"
3
® catheter. Inspect the catheter for
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76%, Omnipaque
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catheter