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

Model Number	PMXENGN
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
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 left iliac vein using a penumbra engine (engine) and a penumbra engine canister (canister).During the procedure, the hospital staff placed the canister onto the engine and noticed that only three of the four indicator lights around the power button on the engine were illuminated when the engine was powered on.It was reported that the physician attempted to use the engine and canister to aspirate; however, after a few minutes, the physician noticed that the engine was not producing adequate aspiration.To troubleshoot, the hospital staff removed the canister, inspected the lid of the canister, and placed it back onto the engine; however, it was unsuccessful.Subsequently, the hospital staff opened a new canister and placed it onto the engine; however, the same issue occurred.Therefore, the engine was not used for the remainder of the procedure.The procedure was completed using another engine and the new canister.There was no report of an adverse effect to the patient.After the procedure was successfully completed, the penumbra sales representative reconnected the first canister to the first engine; however, the same issue occurred.Subsequently, the penumbra sales representative placed the first canister onto the second engine and noted that the engine worked fine, and all four indicator lights were illuminated.
Additional Manufacturer Narrative
Evaluation of the returned engine confirmed a low vacuum pressure.During functional testing, the engine was tested with a demonstration canister, and a low vacuum pressure was observed and only two of four vacuum indicator lights illuminated.The engine housing was opened, and no damage was observed to the tubing.Further evaluation revealed that three of the four dampeners were damaged and loose from the base.The root cause of this damage could not be determined; however, the cause of this damage may have contributed to the engines inability to achieve sufficient vacuum pressure.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: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12229557
• Report Number: 3005168196-2021-01663
• Device Sequence Number: 3444538
• Product Code: QEW
• UDI-Device Identifier: 00815948020030
• UDI-Public: 00815948020030
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K180105
• 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): 08/26/2021
• 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
• Device Catalogue Number: PMXENGN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Date Report Sent to FDA: 01/01/2005