Catalog Number PMXENGN |
Device Problem
Suction Problem (2170)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
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Event Description
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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.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #3005168196-2019-01474 mfr report: 1.Section h.Box 5.Labeled for single use? 2.Section h.Box 8.Usage of device.Conclusion: evaluation of the returned engine revealed a functional device.During functional testing the engine was able to produce a vacuum pressure within specification with all four vacuum indicator lights illuminated.The canister associated with the complaint was not returned for evaluation.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.H3 other text : placeholder.
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Search Alerts/Recalls
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