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

Catalog Number IAPS3

Device Problems Decrease in Pressure (1490); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

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 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
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 8461284
• MDR Text Key: 140268696
• Report Number: 3005168196-2019-00595
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548019765
• UDI-Public: 00814548019765
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K180105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,02/28/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: IAPS3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR