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 04/20/2021

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 right m1 segment of the middle cerebral artery (mca) using a penumbra engine canister (canister) and penumbra engine (engine).During the procedure, as the physician was attempting the first pass, they noticed the canister would not build vacuum pressure to aspirate.It was reported that all four indicator lights on the engine were not illuminated.Therefore, the canister 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 secured properly to the body.During functional testing, the canister was tested on a demonstration engine and was unable to hold vacuum pressure and no vacuum indicator lights illuminated.After securing the canister lid properly, the canister was able to hold vacuum pressure within specification and all four vacuum indicator lights illuminated.The canister lid not being secure to the body likely contributed to the inability to hold vacuum pressure during the procedure and the functional test.The root cause of this issue could not be determined.The supplier performs 100% visual and functional inspection prior to shipping to penumbra.Penumbra performs packaging and label inspection upon receipt prior to shipment to customer.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: 11832606
• MDR Text Key: 250945874
• Report Number: 3005168196-2021-01056
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/20/2021

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
• Device Catalogue Number: PAPS3
• Device Lot Number: S11755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• 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: 04/20/2021
• Initial Date FDA Received: 05/17/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 73