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

Model Number PMXENGN-A

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure to treat a deep vein thrombosis (dvt) using a penumbra engine (engine).During the procedure, the engine would stall and stopped aspirating; however, was able to still power on.The physician attempted to troubleshoot the engine by powering on and off as well as changing the power outlet that was used and, replacing with a new penumbra engine canister (canister); but the same issue occurred.It was also reported that all four lights on the engine were illuminated.Therefore, the engine was removed.The procedure was completed using a penumbra system aspiration pump max 110 (pump max).There was no report of an adverse effect to the patient.

Manufacturer Narrative

Conclusions: evaluation of the returned engine confirmed a non-functional device.The engine was powered on and the fan could be heard, but no vacuum pressure was present, and no vacuum indicator lights illuminated.The engine housing was opened, and frayed wires were observed.This damage likely contributed to the reported complaint.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.H3 other text : placeholder.

• Brand Name: PENUMBRA ENGINE
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10037412
• MDR Text Key: 190287602
• Report Number: 3005168196-2020-00629
• Device Sequence Number: 1
• Product Code: NRY
• 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: 01/01/2005,04/15/2020

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
• Device Lot Number: S10135-33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• 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: 04/15/2020
• Initial Date FDA Received: 05/08/2020
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR