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: 3005168196-2019-01630.
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The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra engine (engine) and a penumbra engine canister (canister).During the procedure, the physician reported that the engine was not reaching full suction and that only three indicator lights were illuminating.The physician attempted to remove the canister to get it to seat better but reported that the same issue persisted.The canister was therefore removed and was no longer used in the procedure.The procedure was completed using another canister and the same engine; however, it was reported that the engine's' suction was still inconsistent.There was no report of an adverse effect to the patient.
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