The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) using an indigo system aspiration catheter 6 (cat6).During the procedure, the physician experienced resistance while advancing a cat6 over a wire into a 6f non-penumbra sheath using the peel away sheath, and the distal tip of the cat6 was crushed.Therefore, the cat6 was removed.The procedure was successfully completed using a new cat6 and another sheath.There was no report of an adverse effect to the patient.
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