The patient was under going a thrombectomy procedure using a penumbra engine pump (engine).During the procedure, the hospital staff discovered only one light would illuminate.Therefore, the penumbra engine canister (canister) was removed and reseated to ensure a good seal between the canister and the engine; however, the engine would still illuminate only one light and was unable to achieve maximum aspiration.The physician was able to achieve reperfusion and the procedure was completed using the same engine.It was reported that after the procedure, the hospital staff went through the troubleshooting steps and was able to achieve maximum aspiration and all four lights would illuminate on the engine.There was no report of an adverse effect to the patient.
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Results: the engine was able to produce a vacuum pressure of approximately -29.5 inhg.A demonstration canister was seated onto the returned engine and was able to hold a vacuum pressure of approximately -28.0 inhg.Conclusions: evaluation of the returned engine revealed a functional device.A demonstration canister was seated onto the returned engine and was able to hold a vacuum pressure within specification with all four vacuum indicator lights illuminated.The reported complaint was unable to be confirmed.Penumbra engines are inspected at incoming quality control which includes a visual inspection as well as a verification of test results to ensure specifications for each output are met.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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