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: 3005168196-2020-01836.
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The patient was undergoing a thrombectomy procedure in the left common iliac artery using indigo system aspiration catheter 8s (cat8s) and a non-penumbra sheath.During the procedure, while advancing the cat8 into the sheath, the physician experienced resistance, and the distal end of the cat8 kinked.Subsequently, the cat8 was removed.The physician continued with the procedure using a second cat8 and completed five passes.While attempting to make the next pass, the physician noticed the cat8 was unable to aspirate the thrombus.Therefore, the cat8 was removed.The procedure was completed using a new catheter and thrombolytic therapy.There was no report of an adverse effect to the patient.
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