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

Model Number	PAPS3-A
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2020
Type of Reportable Event	Malfunction
Additional 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, 3005168196-2020-00590.
Event or Problem 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.
Additional Manufacturer Narrative
Results: no damage was observed on the returned canister.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 2.3005168196-2020-00590 h3 other text : placeholder.

• Brand Name: PENUMBRA ENGINE CANISTER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9991561
• Report Number: 3005168196-2020-00589
• Device Sequence Number: 777578
• Product Code: NRY
• UDI-Device Identifier: 00814548010007
• UDI-Public: 00814548010007
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K180008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: 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 to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005