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

Model Number	PMXENGN
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
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 number: 3005168196-2021-00113.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left popliteal artery using a penumbra engine (engine) and penumbra engine canister (canister).During the procedure, the hospital staff setup the canister and engine.After turning on the engine, it was noticed that the vacuum pressure was low and the indicator lights on the engine did not illuminate.Therefore, the engine and canister were removed.The procedure was completed using another thrombectomy system.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned canister revealed a functional device.During functional testing, the canister was tested on a demonstration engine, and the canister was able to hold a vacuum pressure within specification and all four vacuum indicator lights illuminated.Further evaluation revealed that blood residue was on the canister filter, the canister inlet, and the foam padding on back of the canister.This indicates that the device was likely used during the procedure.Evaluation of the returned engine confirmed a low vacuum pressure, and the vacuum indicator lights did not illuminate.The engine housing was opened, and a tubing was found to be disconnected due to a fractured vacuum sensor barb.The root cause of this damage could not be determined; however, this damage likely contributed to the reported complaint.The supplier performs 100% visual and functional inspection prior to shipping to penumbra.Penumbra performs packaging and label inspection upon receipt prior to shipment to customer.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 number: 3005168196-2021-00113.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: 11191339
• Report Number: 3005168196-2021-00114
• Device Sequence Number: 10954217
• Product Code: QEW
• UDI-Device Identifier: 00815948020030
• UDI-Public: 00815948020030
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• PMA/510(K) Number: K180105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020
• 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
• Device Lot Number: S10189-56
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Date Report Sent to FDA: 01/01/2005