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.This report is associated with mfr report number: 3005168196-2021-01784, 3005168196-2021-01786.
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The patient was undergoing a thrombectomy procedure in the peroneal and posterior tibial using an indigo system aspiration catheter 6 (cat6) and a non-penumbra sheath.During the procedure, while inserting a cat6 using a peel-away sheath into the sheath, the physician experienced resistance.Subsequently, the physician stretched and ovalized the distal tip of the cat6; therefore, the cat6 was removed.The physician then completed one pass using a new cat6 that removed some clot.Afterwards, while re-inserting the cat6 through the peel-away sheath, the physician experienced resistance at the distal tip of the cat6.Subsequently, the physician kinked the cat6; therefore, the cat6 was removed.Then, while attempting to advance a penumbra system ace 68 reperfusion catheter (ace68) through the sheath, the physician experienced resistance.Subsequently, the physician ovalized the distal end of the ace68.Therefore, the ace68 and sheath were removed.The procedure was completed using a new cat6 and a new non-penumbra sheath.There was no report of an adverse effect to the patient.
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