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

Model Number PMXENGN-A

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra engine (engine) and penumbra engine canisters (canisters).During the procedure, the power button on the engine became stuck, and the physician decided to leave the engine on with a canister in place.Once the blood volume in the canister reached the maximum capacity, the hospital staff attempted to power off the engine to switch to another canister, but the power button was not functioning.The power cord of the engine was then disconnected.After the second canister was placed into the engine, the engine would not power on.Therefore, the engine was not used for the remainder of the procedure.The procedure was completed using another engine.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the engine was powered on and off multiple times without an issue.The engine was tested with a demonstration canister and produced vacuum pressure within specification and all four vacuum indicator lights illuminated.The engine was then powered on and off multiple times while under aspiration without an issue.Conclusions: evaluation of the returned engine could not confirm the reported complaint.During functional testing, the engine was powered on and off multiple times using the power button without an issue.The engine was tested with a demonstration canister and produced vacuum pressure within specification and all four vacuum indicator lights illuminated.The engine was then powered on and off multiple times while under aspiration without an issue.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.

• Brand Name: PENUMBRA ENGINE
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10449315
• MDR Text Key: 204247053
• Report Number: 3005168196-2020-01273
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00815948020023
• UDI-Public: 00815948020023
• Combination Product (y/n): Y
• PMA/PMN Number: K180008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/28/2020

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 Model Number: PMXENGN-A
• Device Catalogue Number: PMXENGN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• 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: 07/28/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 09/14/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR