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

Model Number	PMXENGN-A
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2021-02575.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the iliac vein and inferior vena cava (ivc) using a penumbra engine (engine) and a lightning aspiration tubing (lightning).During the procedure, while aspirating clot using the engine and the lightning, the engine lost power towards the end of the procedure.To troubleshoot, the engine was power cycled, and the lightning was unplugged and re-plugged into the engine; however, the issue was not resolved.It was reported that a new lightning was plugged into the engine; however, the lightning unit did not power on.Therefore, the first lightning and engine were not used for the remainder of the procedure.Next, the physician plugged the new lightning into another engine and the lightning unit powered on; however, upon powering on the engine, it was reported only two of the four indicator lights illuminated, and the indicator lights were very dim.The procedure was completed using the new lightning and the second engine with only two of the four indicator lights illuminated.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was inadvertently discarded and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2021-02575.H3 other text: placeholder.

• Brand Name: PENUMBRA ENGINE
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12807240
• Report Number: 3005168196-2021-02574
• Device Sequence Number: 5485238
• Product Code: QEW
• UDI-Device Identifier: 00815948020023
• UDI-Public: 00815948020023
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K180105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005