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

Model Number PMXENGN-A

Device Problems Crack (1135); Suction Problem (2170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2021

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 using a penumbra engine (engine).During the procedure, the engine was noticed to be cracked and not functioning properly.The crack was noticed during the start of the procedure when the four indicator lights would not initiate, and the vacuum pressure was sub-par.Therefore, the engine was not used for the remainder of the procedure.The procedure was completed using another pump.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned engine confirmed that vacuum could not be achieved.Evaluation also revealed that the black lid to the engine was separated from the housing.This is likely the reported crack.During the functional test, the engine was powered on and vacuum could not be achieved within specification, no vacuum indicator lights were illuminated, and engine did not vibrate on the table.The engine housing was opened, and the vacuum tubing barb was fractured off the sensor.This likely contributed to the engine not achieving vacuum within specification.Further evaluation revealed that the one of the screws to the lid was loose an another one of the screws was fractured from the lid.This damage likely contributed to the black lid being separated from the housing.The root cause of this damage could not be determined.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the damage noted on the engine.

• Brand Name: PENUMBRA ENGINE
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11616774
• MDR Text Key: 243912106
• Report Number: 3005168196-2021-00688
• 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: 01/01/2005,06/24/2021

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: 05/18/2021
• 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: 03/09/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 05/27/2021
• Supplement Dates FDA Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1