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 pump max canister (canister) and penumbra system aspiration pump max 110 (pump max).During the procedure, the physician connected the canister to the pump max and adjusted the regulator knob after turning on the power; however, the pump max was unable to achieve full aspiration.Therefore, the canister was removed.The procedure was completed using a new canister and the same pump max.There was no report of an adverse effect to the patient.
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