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 using a penumbra system aspiration pump max 110 (pump max).During the procedure, the physician powered up the pump max and it did not work.It was reported that the gauge read "0" and the pump max would not aspirate; therefore, the pump max was removed.The procedure was completed using manual aspiration.There was no report of an adverse effect to the patient.
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