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

Model Number PAPS3

Device Problem Suction Problem (2170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.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), aspiration tubing (tubing), penumbra system ace 68 reperfusion catheter (ace68), and non-penumbra stent retriever.During the procedure, the physician attached the canister and turned on the engine; however, the engine was not able to produce full aspiration level.The physician checked to see if the tubing was plugged in and the lid to the canister was properly sealed.The canister was then reseated but the same issue occurred and, therefore, it was removed.The procedure was completed using a new canister and the same engine.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned canister revealed that the lid was not properly fastened on the canister housing.If this occurs, air leakage may occur at the lid and vacuum pressure may not build up inside the canister.The root cause of this issue could not be determined.During functional testing, after the canister lid was sealed properly on the canister housing, the device was tested with a demonstration engine and was able to achieve 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.H3 other text : placeholder.

• Brand Name: PENUMBRA ENGINE CANISTER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12028967
• MDR Text Key: 257184956
• Report Number: 3005168196-2021-01370
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019758
• UDI-Public: 00814548019758
• 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: 01/01/2005,07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PAPS3
• Device Catalogue Number: PAPS3
• Device Lot Number: S11759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR