Physician intended to use a hawkone atherectomy device with a spider fx embolic protection device during treatment of a plaque lesion located in the patient¿s proximal, mid, and distal right superficial femoral artery (sfa) and popliteal artery (pa).Moderate vessel tortuosity and slight calcification are reported.Lesion exhibited 80% stenosis.Ifu was followed.The guidewire was hydrated during preparation.Vessel pre-dilation was not preformed.It is reported the hawkone was used over the spider fx device.The device was advanced over the bifurcation.The spider wire is reported to have prolapsed during the procedure.When the physician attempted to advance the hawkone device, the distal end of the rapid exchange port at the tip is reported to have torn.Tip damage is reported, and the guidewire lumen was torn form the distal tip.It was reported that the rapid exchange port along the stationary part of the nosecone came off the spider wire within the patient.The guidewire is not reported to have locked up on the catheter.The hawkone device and spider fx were removed successfully with no intervention required.There was no vessel damage noted.The devices were replaced with another spider fx and hawkone device to complete the procedure.No patient injury reported.
|