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

Model Number	PMXENGN-A
Medical Device Problem Codes	Crack (1135); Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
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 using a penumbra engine (engine).During the procedure, the engine was noticed to be cracked and not functioning properly.The crack was noticed during the start of the procedure when the four indicator lights would not initiate, and the vacuum pressure was sub-par.Therefore, the engine was not used for the remainder of the procedure.The procedure was completed using another pump.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned engine confirmed that vacuum could not be achieved.Evaluation also revealed that the black lid to the engine was separated from the housing.This is likely the reported crack.During the functional test, the engine was powered on and vacuum could not be achieved within specification, no vacuum indicator lights were illuminated, and engine did not vibrate on the table.The engine housing was opened, and the vacuum tubing barb was fractured off the sensor.This likely contributed to the engine not achieving vacuum within specification.Further evaluation revealed that the one of the screws to the lid was loose an another one of the screws was fractured from the lid.This damage likely contributed to the black lid being separated from the housing.The root cause of this damage could not be determined.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the damage noted on the engine.

• Brand Name: PENUMBRA ENGINE
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11616774
• Report Number: 3005168196-2021-00688
• Device Sequence Number: 11544488
• Product Code: NRY
• UDI-Device Identifier: 00815948020023
• UDI-Public: 00815948020023
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180008
• 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): 06/24/2021
• 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: 05/18/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005