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

Model Number PAPS3

Device Problems Crack (1135); Suction Problem (2170)

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

Event Date 08/19/2021

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 using a penumbra engine canister (canister) and a penumbra engine (engine).During the procedure, one of the engine indicator lights was not illuminated.The canister and aspiration tubing (tubing) were disconnected and re-connected twice but the issue did not resolve.It was reported that the canister lid felt loose.Therefore, the canister was removed.After the canister was returned to the distributor, it was found that the lid was cracked.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 could not confirm the reported complaint.The lid was inspected for a crack, but the observed damaged was determined to be scuff marks.The cause of this damage could not be determined, and the damage did not affect the canister''s ability to hold vacuum pressure.During functional testing, the canister was tested on a demonstration engine.The engine was able to achieve vacuum pressure within specification, and all four vacuum indicator lights illuminated.The root cause of the reported complaint 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.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: 12474559
• MDR Text Key: 271483641
• Report Number: 3005168196-2021-02036
• 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: 01/01/2005,10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• 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: S11880
• Was Device Available for Evaluation?: Yes
• 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: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR