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 anterior tibial artery using an indigo system aspiration catheter 6 (cat6).During the procedure, the physician experienced resistance while attempting to insert the cat6 into a non-penumbra sheath.Consequently, the distal tip of the cat6 became bent and, therefore, it was removed.The procedure was completed using a new cat6 with a new non-penumbra sheath.There was no report of an adverse effect to the patient.
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