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	06/30/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10404638
• Report Number: 3005168196-2020-01183
• Device Sequence Number: 2991224
• Product Code: NRY
• UDI-Device Identifier: 00814548010007
• UDI-Public: 00814548010007
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K180008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2020
• 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: 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 to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/21/2020; 01/14/2005
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 09/16/2020; 06/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005