MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA ENGINE; NRY

Model Number	PMXENGN-A
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right main pulmonary artery using a lightning aspiration tubing (lighting) and a penumbra engine (engine).During the procedure, the lightning was connected to the engine and powered on.However, none of the indicator lights on the lightning unit illuminated, even though the engine had all four indicator lights illuminated and full aspiration was achieved.Therefore, the lightning was removed.Afterwards, a new lightning was connected to the engine and powered on; however, the same issue occurred.To troubleshoot, the engine was removed, and the second lightning was connected to a second engine and it was noted that the second lightning unit worked.It was reported that there were no attempts to check if the first lightning worked using the second engine; however, there was no allegation against the first lightning.It was believed to be an issue with possibly the usb port on the first engine.The procedure was completed using the same second lightning and the same second engine.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned engine confirmed a non-functioning usb port.During functional testing, the engine was powered on and was able to achieve vacuum pressure within specification and all four vacuum indicator lights illuminated.A demonstration lightning unit was connected to the engine, but no indicator lights on the lightning unit illuminated.The engine housing was opened, and the wire that connects to the type-c usb port was found to be disconnected.After reconnecting the wire, the lightning unit was connected to the engine and the indicator lights on the lighting unit illuminated.The disconnected wire likely contributed to the usb port not functioning properly.The root cause of this damage could not be determined.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.

• Brand Name: PENUMBRA ENGINE
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11608351
• Report Number: 3005168196-2021-00663
• Device Sequence Number: 3086251
• Product Code: NRY
• UDI-Device Identifier: 00815948020023
• UDI-Public: 00815948020023
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PMXENGN-A
• Device Catalogue Number: PMXENGN
• Device Lot Number: S10152-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005