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

Model Number PAPS3-A

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2020-00588, 3005168196-2020-00589.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra engine (engine) and penumbra engine canisters (canisters).During the procedure, the engine was not maintaining full vacuum pressure.All four indicator lights on the engine were illuminated at the start but would drop down to two indicator lights.The hospital technologist attempted to troubleshoot the engine by removing the lid of the first canister and then placing it back on; however, the issue was not resolved.The technologist then switched to a second canister; however, the same issue occurred.The procedure was completed using the same engine and a third canister.It was reported that in order to maintain full vacuum pressure, the technologist had to press down on the third canister throughout the procedure.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the canister lid was not properly sealed on the canister body.One of the lid hook features was not fully engaged with the hook on the canister body.Conclusions: evaluation of the returned engine revealed an undamaged and functional device.During functional testing, a demonstration canister was seated on the returned engine and the engine was able to produce a vacuum pressure within specification.All four vacuum indicator lights illuminated.Evaluation of the returned canister revealed an undamaged and functional device.During functional testing, the returned canister was seated onto the returned engine and was able to produce a vacuum pressure within specification.All four vacuum indicator lights illuminated on the engine.The root cause of the reported complaint could not be confirmed.Evaluation of the second canister revealed that the canister lid was not properly sealed on the canister body.One of the lid hook features was not fully engaged with the hook on the canister body.During functional testing, the canister lid was opened and retightened properly.Then the canister was seated on the returned engine and able to generate vacuum pressure within specification.All four vacuum indicator lights illuminated on the engine.Penumbra engines and canisters are 100% visually inspected and functionally tested by the supplier.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 1.3005168196-2020-00588, 2.3005168196-2020-00589.

• Brand Name: PENUMBRA ENGINE CANISTER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9991563
• MDR Text Key: 188695094
• Report Number: 3005168196-2020-00590
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548010007
• UDI-Public: 00814548010007
• 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: 01/01/2005,03/31/2020

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: PAPS3-A
• Device Catalogue Number: PAPS3
• Device Lot Number: S11573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• 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: 03/31/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 05/13/2020
• Supplement Dates FDA Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR