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

Catalog Number	PAPS3
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2020
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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2020-01530, 3005168196-2020-01531.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a pulmonary embolism (pe) using a penumbra engine (engine) and a penumbra engine canister (canister).While setting up for the procedure, the engine was inadvertently dropped on the floor.During the procedure, while the engine was in use in the patient, it was unable to reach the maximum vacuum pressure.It was reported that only one to two of the engine indicator lights were illuminating.The physician powered the engine on and off, and exchanged the canister for a new one; however, the issue persisted.Therefore, the engine and canister were no longer used in the procedure.The procedure was completed using a penumbra system aspiration pump max (pump max).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: 10567299
• Report Number: 3005168196-2020-01532
• Device Sequence Number: 11439177
• Product Code: DXE
• UDI-Device Identifier: 00814548019758
• UDI-Public: 00814548019758
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K180105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2020
• 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: PAPS3
• 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: 08/24/2020
• Initial Report FDA Received Date: 09/22/2020
• 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