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

Model Number	PMXENGN
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned engine revealed that the housing was not secured properly to the base.During functional testing, a demonstration canister was unable to be seated onto the engine properly.The engine was unable to produce vacuum pressure within specification and no vacuum indicator lights illuminated.The engine housing was opened, and a screw port was observed to be damaged, and a screw was stuck in the port.The root cause of this damage could not be determined; however, the cause of this damage likely contributed to the housing not being secured to the base properly.After securing the engines housing to the base properly, the demonstration canister was able to seat properly on the engine.The engine was then able to produce vacuum pressure within specification and all four vacuum indicator lights illuminated.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra engine (engine) and a penumbra engine canister (canister).During the procedure, the canister was placed onto the engine and then the engine was powered on.However, no vacuum was achieved.It was reported that none of the indicator lights on the engine turned on and that no suction was generated unless the hospital technologist held the canister down; therefore, the engine was disconnected, and the canister was removed from the engine.The procedure was completed using the same canister and a second engine.There was no report of an adverse effect to the patient.After the procedure was successfully completed, the physician attempted to connect another canister to the first engine; however, the canister would not seat properly onto the first engine.

• Brand Name: PENUMBRA ENGINE
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11801810
• Report Number: 3005168196-2021-00998
• Device Sequence Number: 1020459
• Product Code: NRY
• UDI-Device Identifier: 00815948020030
• UDI-Public: 00815948020030
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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
• Report Date (Section B): 04/12/2021
• 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
• Device Catalogue Number: PMXENGN
• Device Lot Number: S10195-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• 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: 04/12/2021
• Initial Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005