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 06/30/2020

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 canister (canister) and a penumbra engine (engine).During the procedure, when the aspiration tubing (tubing) was connected to the patient, the penumbra engine (engine) indicator lights were not turning on and no aspiration was being produced.Therefore, the tubing was removed from the patient and the canister and engine were no longer used.The procedure was completed using a non-penumbra aspiration device.There was no report of an adverse effect to the patient.It was reported that on the following day a new canister was tested with the same engine and the issue resolved.

Manufacturer Narrative

Results: the canister lid was not properly sealed on the canister body.Conclusions: evaluation of the returned canister revealed that the canister lid was not properly sealed on the canister body.This damage likely contributed to the reported the canister not producing aspiration during the procedure.During functional testing, the canister lid was opened and re tightened.Then the canister was able to generate vacuum pressure within specification.Penumbra 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.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #02 mfr report: 3005168196-2020-01183.Section b.Box 5.Describe event or problem h3 other text : placeholder.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra engine canister (canister), penumbra engine (engine).During the procedure, when the aspiration tubing (tubing) was connected to the penumbra system ace 68 reperfusion catheter (ace68), the engine indicator lights were not turning on and no aspiration was being produced.Therefore, the tubing was removed from the ace68 and the ace68, the canister and engine were no longer used.The procedure was completed using a non-penumbra aspiration device.There was no report of an adverse effect to the patient.It was reported that on the following day a new canister was tested with the same engine and the issue resolved.

• Brand Name: PENUMBRA ENGINE CANISTER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10404638
• MDR Text Key: 202865869
• Report Number: 3005168196-2020-01183
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,07/01/2020

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: S11516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• 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: 07/01/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 08/21/2020; 01/14/2005
• Supplement Dates FDA Received: 09/16/2020; 06/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1