flexible tip up to the central most extent of the clot. Uncover the sinuous
wire by unlocking, fully retracting the sliding lever and rotating the sliding
lever until an audible "click" is heard. Confirm device positioning within the
fistula or graft via fluoroscopy. Press the ON/OFF switch to activate rotation.
19. With the device activated, slowly withdraw the rotating sinuous wire, in the
uncovered position, along the graft or fistula to break up the clot. Warning:
A withdraw rate of 1-2 cm/second is recommended when sharp radii
are encountered. When the sinuous wire reaches the tip of the arterial
sheath, release the switch to turn off the rotator.
20. Cover the device and remove it from the graft or fistula. Flush the catheter
lumen with heparinized saline and manually remove any accumulated fibrin
from the sinuous wire.
21. Aspirate the macerated clot using either sheath and discard the aspirate.
Precaution: Continued unsuccessful aspiration may collapse the
sheath and graft/fistula.
22. Pass an appropriate catheter through the arterial sheath, and carefully feed
it past the arterial anastomosis of the graft or fistula. Inflate the balloon, if it
is a balloon catheter. Pull the arterial plug into the middle of the arterial limb.
Deflate the balloon and remove the balloon catheter.
23. Reinsert the covered CLEANER 15
the arterial limb of the graft or fistula.
24. Uncover the sinuous wire and activate the device to break up the arterial
plug, using contrast to guide maceration.
25. Cover the device and remove it from the graft or fistula. Flush the catheter
lumen with heparinized saline and manually remove any accumulated fibrin
from the sinuous wire.
26. Aspirate the macerated clot via the sheath and discard the aspirate.
27. Inject contrast to assess the degree of thrombus removal. Treat any
residual thrombus using the CLEANER 15
28. When the thrombus removal is complete, treat any underlying disease or
stenosis per hospital protocol.
29. Perform the final fistulogram.
30. Remove the sheaths from the fistula or graft.
31. Achieve hemostasis at the puncture site(s) per hospital protocol.
Grafts and Fistulae
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device through the arterial sheath into
10
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via either sheath, as needed.