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

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	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-02027, 3005168196-2021-02028, 3005168196-2021-02029.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra engine (engine), a penumbra engine canister (canister), aspiration tubing (tubing), and a penumbra system ace 68 reperfusion catheter (ace68).During the procedure, some of the engine indicator lights did not illuminate when the device was powered on.The technologist exchanged the canister for a new one and attempted to re-seat it in the engine; however, the issue persisted.Therefore, the canister was removed and the tubing was exchanged for a new one.While using the new tubing and a new canister, only two of the engine indicator lights illuminated.Therefore, the engine and the canister were removed from the procedure.The procedure was completed using a new engine, a new canister, the same tubing, and the same ace68.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned engine confirmed the reported complaint.During functional testing, the engine was tested with a demonstration canister and was unable to generate sufficient vacuum pressure, and only two of the four vacuum indicator lights illuminated.While powered on, the engine sounded louder than normal, and a hissing noise could be heard.Upon opening the housing, no damage was observed, and all the tubing were connected.Further evaluation revealed that the engine housing had multiple cracks on the front of the housing, and the black lid was separated from the housing in one area.The probable cause of this damage may be due to the device becoming impacted by an external force.The root cause of this damage could not be determined; however, the cause of this damage may have also contributed to the engine not functioning properly.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported issue with the engine not reaching full vacuum.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12465484
• Report Number: 3005168196-2021-02026
• Device Sequence Number: 11707085
• Product Code: NRY
• UDI-Device Identifier: 00815948020023
• UDI-Public: 00815948020023
• Combination Product (Y/N): Y
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K180008
• 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): 11/09/2021
• 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
• Device Lot Number: S10163-XX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• 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: 08/17/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005