(b)(4).Device evaluated by manufacturer: a visual examination identified 3 areas of buckling/kinks on the shaft located 3cm, 3.5cm and 5.5cm from the tip.A.014 guidewire was inserted into the device and the wire transcended through the device with no restrictions or hesitations.The device was inserted into the jetstream console and set up per the dfu, the device ran as designed.No issues with the blades not spinning.Visual examination noticed that the infusion line had burst proximal the kinks and damage.The location of the burst infusion line was approximately 12cm from the tip of the catheter.The damage noticed is consistent with sheath interference during the procedure.Pushing, pulling and torqueing of the device could possibly contribute to the damage.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
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It was reported the catheter bogged down and a dissection occurred.A rotational atherectomy treatment procedure was being performed in the non tortuous mid superficial femoral artery (sfa).A 2.4mm jetstream xc atherectomy catheter was primed and noted to be functioning properly prior to entering the patient.The catheter was advanced over a.014 thruway guidewire and advanced into a non bsc sheath.It was noted there was difficulty inserting the device into the sheath, just past the hemostatic valve.A little force was applied and the catheter was able to be advanced past the valve of the sheath.The catheter was advanced to the location of the diseased area in the sfa and atherectomy of the cto was started.One pass was made halfway through the diseased vessel before the device started to ¿bog down" and drop in rpm¿s.The device also would not advance any further.Fluoroscopy was performed to inspect the device for kinks or tortuosity.The device was "rexd" back a couple of centimeters but ran into the same issue.The device was removed from the patient and upon further inspection, it was noted the outer sheath was delaminated with a fluid filled partition or a ballooning of the proximal 3rd portion of the outer.The atherectomy portion of the case was then ceased and the doctor proceeded to perform an angiography of the affected vessel.A dissection was noted and treated with a stent.No further complications were reported and the patient was reported stable and doing fine.
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