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

Model Number PAPS3-A

Device Problem Suction Problem (2170)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2020

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 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.

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
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11201393
• MDR Text Key: 227793925
• Report Number: 3005168196-2021-00121
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/22/2020

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: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1