The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra engine canister (canister), penumbra engine (engine), and penumbra system 3max reperfusion catheter (3maxc).During the procedure, the physician completed the first pass using the 3maxc.Subsequently, the physician noticed that blood was slowly aspirated back into the canister and only three indicator lights on the engine illuminated.It was reported that the lid of the canister and setting was inspected.Therefore, the canister was removed.The procedure was completed using a new canister with the same engine.There was no report of an adverse effect to the patient.
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Evaluation of the returned canister could not confirm the reported complaint.During functional testing, the canister was seated onto a demonstration engine and was able to produce a vacuum pressure within specification.All four vacuum indicator lights on the engine illuminated.Penumbra canisters are 100% visually inspected and functionally tested by the supplier.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.
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