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

Model Number	PMXENGN-A
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure for a pulmonary embolism using a penumbra engine (engine).During the procedure, the physician noticed the engine was unable to produce aspiration approximately halfway through the procedure.Therefore, the engine was removed.The procedure was completed using another engine.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information received from the device return on 01/11/2021: 1.Section d.Box 4.Serial #.2.Section h.Box 4.Device manufacture date.Evaluation of the returned engine revealed a functional device.The engine was able to power on and produced vacuum pressure within specification.The engine remained powered on for approximately 5 minutes and no decrease in aspiration was observed.The reported complaint could not be confirmed.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: 10955128
• Report Number: 3005168196-2020-02198
• Device Sequence Number: 2177745
• Product Code: QEW
• UDI-Device Identifier: 00815948020023
• UDI-Public: 00815948020023
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 11/10/2020
• 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-A
• Device Catalogue Number: PMXENGN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Date Report Sent to FDA: 01/01/2005