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

Model Number	PMXENGN-A
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
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 to treat an arteriovenous (av) graft in the upper arm using a penumbra engine (engine).During the procedure, the engine would not power on.The penumbra sales representative made several attempts to turn the engine on and plugged the engine into multiple working electrical plugs; however, the engine would not turn on.Therefore, the engine was not used for the remainder of the procedure.The procedure was completed using an embolectomy balloon and aspiration through a catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2021-01103.Section h.Box 5.Labeled for single use? section h.Box 8.Usage of device.Evaluation of the returned engine confirmed that the device would not power on.During functional testing, the engine was plugged in and power button was pressed, but the device would not power on.The fuses on the back of the engine were replaced with known good fuses, and the engine was then able to power on and produce vacuum pressure within specification, and all four vacuum indicator lights illuminated.The root cause of the blown fuses could not be determined; however, this damage likely contributed to the engines inability to power on during the procedure and the functional test.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.

• Brand Name: PENUMBRA ENGINE
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11848861
• Report Number: 3005168196-2021-01103
• Device Sequence Number: 17085519
• Product Code: QEW
• UDI-Device Identifier: 00815948020023
• UDI-Public: 00815948020023
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 04/23/2021
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005