MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA ENGINE CANISTER; DXE

Catalog Number	IAPS3
Medical Device Problem Codes	Decrease in Pressure (1490); Pressure Problem (3012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) using a penumbra engine canister (canister).During the procedure, after accumulating 75 cc of blood, a penumbra staff discovered only three lights on the penumbra engine (engine) would illuminate.However, all four lights would illuminate when the penumbra staff held his finger over the ventilation hole on the lid of the canister.It was reported that the procedure continued with only three lights on the engine and the hole was covered when needed by the penumbra staff.The procedure was completed using the same engine with the same canister.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA ENGINE CANISTER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8461284
• Report Number: 3005168196-2019-00595
• Device Sequence Number: 16897427
• Product Code: DXE
• UDI-Device Identifier: 00814548019765
• UDI-Public: 00814548019765
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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
• Report Date (Section B): 02/28/2019
• 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 Catalogue Number: IAPS3
• Was Device Available for Evaluation?: No
• 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: 02/28/2019
• Initial Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005