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 ace 68 reperfusion catheter (ace68).During the procedure, after one pass was made, the aspiration speed slowed, and the indicator lights on the engine were off.The physician reset the devices twice and checked the lid of the canister.The indicator lights remained off, and the flow switch was off.Therefore, the canister was removed.The procedure was completed using a new canister and the same engine and ace68.There was no report of an adverse effect to the patient.
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Evaluation of the returned canister revealed a functional device.During functional testing, the canister was tested with a demonstration engine, and the canister was able to hold vacuum pressure within specification and all four vacuum indicator lights illuminated on the engine.The root cause of the reported complaint could not be determined.The supplier performs 100% visual and functional inspection prior to shipping to penumbra.Penumbra performs packaging and label inspection upon receipt prior to shipment to customer.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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