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 m1 segment of the middle cerebral artery (mca) using a penumbra engine canister (canister).During the procedure, the canister did not provide adequate suction.It was reported that the canister did not provide a good seal for the penumbra engine pump (engine).Therefore, the procedure was completed using another canister.There was no report of an adverse effect to the patient.
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