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

Model Number	PMXENGN-A
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned engine revealed a functional device.During functional testing, the engine was tested with a demonstration canister and was able to produce vacuum pressure within specification.All four vacuum indicator lights illuminated; therefore, the reported complaint could not be confirmed.Further evaluation of the device revealed that the engine vacuum port plugs were not present on the engine vacuum inlet.Based on the complaint, the vacuum port plugs were removed during the procedure to troubleshoot the engine.Therefore, this damage was incidental to the complaint.The reported depressed vacuum release lever could not be confirmed.Penumbra engines are visually inspected and functionally tested during incoming quality inspection.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 number: 3005168196-2021-01289.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the coronary artery using a penumbra engine (engine) and penumbra engine canister (canister).During the procedure, the physician noticed none of the indicator lights on the engine would illuminate and the engine was not generating aspiration.The grommets near the canisters were removed in an attempt to troubleshoot; however, it was unsuccessful.It was also reported that the vacuum release lever was depressed.Therefore, engine was removed.The procedure was completed using a manual aspiration 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.1.Section h.Box 5.Labeled for single use?, 2.Section h.Box 8.Usage of device.This report is associated with mfr report number: 1.3005168196-2021-01289.

• Brand Name: PENUMBRA ENGINE
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11971308
• Report Number: 3005168196-2021-01288
• Device Sequence Number: 4229423
• Product Code: QEW
• UDI-Device Identifier: 00815948020023
• UDI-Public: 00815948020023
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 05/14/2021
• 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: 05/20/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005