The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra max canister (canister).During the procedure, the physician noticed that the tubing connected to the filter of the penumbra system aspiration pump max 110 (pump max) had blood in it; therefore, the canister was removed.The procedure was completed using another canister and the same pump max.There was no report of an adverse effect to the patient.
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Results: blood was within the canister and the canister tubing.The filter in the canister lid was covered with blood.Conclusions: evaluation of the returned canister confirmed that blood was within the canister tubing.Further investigation revealed that the canister lid filter was covered in blood.Although blood was aspirated into the canister tubing past the canister lid filter, the in-line filter worked as intended.Blood was kept from entering the pump max.The root cause of blood being aspirated past the canister lid filter could not be determined.Penumbra canisters are visually inspected and functionally tested during incoming quality inspection.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.Section h.Box 6.Results code 1: 4247 - the investigation confirmed that blood was within the canister tubing.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of blood being aspirated past the canister lid filter.
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