10
increments until the stent is fluoroscopically visualized through stricture. Confirm desired
stent position fluoroscopically. NOTE: For transpapillary placement, reference the yellow
endoscopic marker for stent positioning. A stent bridging the papilla should extend
beyond the papilla and into the duodenum approximately 0.5 cm after deployment.
NOTE: Repeat steps 1-4 for second device. Both devices must be in position prior to the
deployment of either stent.
5. Prior to deploying stent(s), remove red safety lock(s). NOTE: Ensure that the red safety
lock(s) is/are not inadvertently removed prior to this step.
6. Under fluoroscopic guidance, with the elevator open begin deployment of stent(s)
by holding the wire guide hub(s) stationary and slowly pulling back on the handle(s).
Simultaneously maintain stent(s) position during deployment by withdrawing the
delivery system(s) from the duodenoscope. WARNING: Do not advance the delivery
system up into the bile duct after stent deployment has been initiated. CAUTION:
The delivery system cannot be readvanced over stent to recapture the stent during
deployment.
7. Continue simultaneously pulling back on the handle(s) and withdrawing the delivery
system(s) until it is fluoroscopically confirmed that the stent(s) is/are completely
deployed. For transpapillary placement, endoscopic confirmation of complete stent
deployment may also be used.
8. While maintaining wire guide position, with the elevator open, carefully remove
the delivery system from within the expanded stent. Remove the delivery system from
the duodenoscope while monitoring the position of the stent fluoroscopically. NOTE:
Fluoroscopically ensure the stent has expanded sufficiently to allow for safe removal of
the tip.
NOTE: Repeat step 8 for removal of second delivery system.
Upon completion of procedure, dispose of device(s) per institutional guidelines for
biohazardous medical waste.
HOW SUPPLIED
Supplied sterilized by ethylene oxide gas in peel-open packages. This device is designed
for single use only. Attempts to reprocess, resterilize, and/or reuse may lead to device
failure and/or transmission of disease. Sterile if package is unopened or undamaged. Do
not use the product if there is doubt as to whether the product is sterile. Store in a dark,
dry, cool place. Avoid extended exposure to light. Upon removal from package, inspect
the product to ensure no damage has occurred. If the package is opened or damaged
when received, do not use the device. Visually inspect the device with particular
attention to kinks, bends, or breaks. If an abnormality is detected that would prohibit
proper working condition, do not use the device. Notify Cook for return authorization.
