The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
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The patient was undergoing a thrombectomy procedure using indigo pump max canister (canister).During the procedure, the hospital staff noticed that the penumbra system aspiration pump max 110 (pump max) could not achieve any vacuum.After troubleshooting, it was noted that the canister was cracked and, 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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