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 aspiration system catheter 6 (cat6).During the procedure, while attempting to advance a cat6 over a guidewire and into a non-penumbra sheath using the peel away sheath, the physician experienced resistance and, the distal tip of the cat6 became crushed.Therefore, the cat6 and sheath were removed.The procedure was completed using a new cat6 and a new sheath.There was no report of an adverse effect to the patient.
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