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

Model Number	PMXENGN
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
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: 3005168196-2021-02154, 3005168196-2021-02155, 3005168196-2021-02156.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary artery using a penumbra engine (engine), penumbra engine canister (canister), lightning aspiration tubing (lightning), an indigo system cat12 aspiration catheter (cat12), indigo system aspiration catheter 8 (cat8), aspiration tubing (tubing).During the procedure, the physician advanced the cat12 proximal to the clot in the target vessel, when the physician plugged the lightning unit into the usb port on the back of the engine, the indicator light on the lightning unit briefly powered on with the green indicator light and then turned off.The engine would power on with all four indicator lights illuminated; however, there was no aspiration at the tip of the cat12 or the tubing.It was also reported that when the hospital staff removed the lightning from the canister, the canister was able to build pressure.The hospital staff also made multiple attempts to disconnect and reconnect the lightning unit into the usb port on the engine to troubleshoot; however, the same issue occurred.Therefore, the lightning was removed.Subsequently, the physician attempted to use two new lightnings with a new cat12, a new cat8, and the same engine; however, the same issue occurred with the two lightning units.The physician made the same troubleshooting attempts, but it was unsuccessful.Therefore, both lightning units, the cat12, and cat8 were removed.The physician decided to end the procedure at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned engine confirmed, an issue with the usb port on the back of the engine.During the functional test, the engine was powered on, and vacuum was achieved within specification.A demonstration lightning unit was connected to the usb port, and the unit did not illuminate.The engine housing was opened, and no visible damage was observed, to the usb connection.All four dampeners were damaged.This damage was likely, incidental to the complaint.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.This report is associated with mfr report numbers: 1.3005168196-2021-02154; 2.3005168196-2021-02155; 3.3005168196-2021-02156.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: 12550945
• Report Number: 3005168196-2021-02153
• Device Sequence Number: 19841612
• Product Code: QEW
• UDI-Device Identifier: 00815948020030
• UDI-Public: 00815948020030
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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): 12/28/2021
• 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: 12/10/2021
• 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: 09/08/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2020
• 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: 65 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005