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

Model Number	PAPS3-A
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2020
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 in the internal carotid artery (ica) using a penumbra engine canister (canister), penumbra engine (engine), and aspiration tubing (tubing).During the procedure, the physician turned on the engine and noticed only three indicator lights would illuminate on the engine.Therefore, the physician removed the tubing from the canister and blocked the port on the canister by hand to have all four lights illuminated on the engine.It was also reported that the physician reattached the tubing back on the canister; however, all four indicator lights on the engine would not illuminate.Therefore, the canister and engine were removed.The procedure was completed using manual aspiration with a syringe.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned canister revealed an undamaged and functional device.During functional testing, the canister was seated onto a demonstration engine and was able to produce a vacuum pressure within specification.All four vacuum indicator lights on the engine illuminated.Evaluation of the returned tubing revealed an undamaged and functional device.During functional testing, the tubing was connected to the returned canister and a demonstration engine, and the tubing functioned properly.All four vacuum indicator lights on the engine illuminated.Evaluation of the returned ace68 revealed an undamaged and functional device.During functional testing, the ace68 was tested with the returned tubing, the returned canister, and a demonstration engine, and the ace68 functioned properly.All four vacuum indicator lights on the engine illuminated.Water was aspirated through the ace68 and the returned tubing without an issue.Penumbra canisters are 100% visually inspected and functionally tested by the supplier.Penumbra catheters and the tubing are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA ENGINE CANISTER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11201393
• Report Number: 3005168196-2021-00121
• Device Sequence Number: 16696904
• Product Code: NRY
• UDI-Device Identifier: 00814548010007
• UDI-Public: 00814548010007
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K180008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020
• 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: S11613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 02/24/2021
• 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