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.This report is associated with mfr report number: 3005168196-2019-01472.
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The patient was undergoing a thrombectomy procedure using a penumbra engine pump (engine) and a penumbra engine canister (canister).During the procedure, the physician reported that all lights of the engine would not illuminate and full aspiration was unable to be achieved.The physician also reported that the canister had too much foam.Therefore, the engine and the canister were removed.The procedure was completed using non-penumbra devices.No additional information is available.
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