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

Model Number	PMXENGN-A
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
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 in the internal carotid artery using a penumbra engine (engine), penumbra engine canister (canister), aspiration tubing (tubing), non-penumbra reperfusion catheter, non-penumbra stent retriever, and non-penumbra aspiration tubing.During the procedure, after the engine was powered on, the indicator lights turned on one by one but were flashing on and off.Subsequently, the physician powered off the engine and replaced the non-penumbra aspiration tubing with the penumbra aspiration tubing.However, the same issue with the engine occurred.Therefore, the engine was removed.The procedure was completed using a penumbra system aspiration pump max 110 (pump max).Post-procedure, the physician confirmed the engine was working fine except for the issue with the indicator lights.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned engine confirmed that the vacuum indicator lights were malfunctioning.During functional testing, the returned engine was able to power on and produce a vacuum pressure within specification.All four indicator lights illuminated but the brightness of the light was very dim and flashing.The engine was tested with a demonstration power button and the same issue occurred.This indicates that a possible malfunction within the main pcb may be contributing to the vacuum indicator lights abnormality.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: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11266661
• Report Number: 3005168196-2021-00206
• Device Sequence Number: 11067451
• Product Code: NRY
• UDI-Device Identifier: 00815948020023
• UDI-Public: 00815948020023
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K180008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021
• 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: 01/21/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Date Report Sent to FDA: 01/01/2005