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

Catalog Number	IAPS3
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2020
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 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 inferior vena cava (ivc) using a penumbra engine canister (canister), a penumbra engine (engine), an indigo system aspiration catheter 8 (cat8), a sheath, and guidewire.During the procedure, the cat8 was advanced over the guidewire and through a sheath.Next, the engine with the canister was connected to the cat8 and the engine was powered on.However, not all four of the indicator lights on the engine illuminated and maximum vacuum pressure was not achieved.To troubleshoot, the canister was removed and placed back into the engine three times.In addition, the engine was powered off and powered on three times; however, the issue was not resolved.Therefore, the engine was disconnected and removed.The physician continued the procedure using another engine and the same canister, but the same issue occurred.Therefore, the canister was removed.The procedure was completed using a new canister and the second engine.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: 10437135
• Report Number: 3005168196-2020-01240
• Device Sequence Number: 3974624
• Product Code: DXE
• UDI-Device Identifier: 00814548019765
• UDI-Public: 00814548019765
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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): 07/27/2020
• 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
• Device Lot Number: S11691
• 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: 07/27/2020
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Date Report Sent to FDA: 01/01/2005