Evaluation summary: a single photographic image was received.The image showed a hawkone cutter assembly with the guidewire lumen zippered from the cutter assembly from its proximal end to approximately the mid-point of the cutter assembly coil.The hawkone h1-m (6fr) was received for evaluation.The hawkone was received with a cutter driver unit, a tweezer, and a 320cm length spiderfx capture wire and filter assembly.The cutter driver unit was functionally tested and performed as expected.The returned cutter exhibited damage - the guidewire lumen on the cutter assembly coil was zippered from the proximal port to approximately the middle of the cutter assembly coil, as seen in the photographic image mentioned.If information is provided in the future, a supplemental report will be issued.
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The physician intended to use a hawkone with a spider fx and non-medtronic 6f sheath, to treat a cto in the proximal superficial femoral artery (sfa) and popliteal artery (pa).The device was prepped as per ifu, moderate resistance was encountered during the procedure.It was reported the physician was unable to cross the proximal sfa, pedal access was attempted but unsuccessful.The physician gained access through the thigh and a 4f sheath was placed.The physician crossed the cto retrograde fashion and snared the wire, the popliteal cto was crossed successfully a spider fx was placed proximal to the anterior tibial (at) takeoff.The physician did one pass over the lesion with the hawkone in anterior popliteal (ap) position, after pulling back and rotating 90 degrees a second pass was made, a kink was observed in the spider, during retrieval resistance was encountered.The hawk was pulled back to the sheath, it was observed that the spider had been pulled back to the mid sfa.The physician worked diligently to remove both devices.On removal the wire port was peeled back, and the spider wire was exiting the proximal end of the nosecone near the cutter.Access was regained across the lesion the procedure was completed using a trailblazer, a non-medtronic.014 wire and chocolate balloon.No patient injury reported.
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