MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER; NRY

Catalog Number	RED43138
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned penumbra system red 43 reperfusion catheter (red43) confirmed that the device was fractured proximal to the markerband.Evaluation revealed stretching at the fractured site indicating that the red43 likely stretched prior to fracturing.If the red43 is retracted against resistance during use, damage such as stretching and subsequent fracture may occur.The root cause of the resistance could not be determined.Further evaluation of the device revealed kinks and ovalization on the catheter.This damage is incidental to the complaint and the root cause could not be determined.Penumbra catheters 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the superior m2 branch of the middle cerebral artery (mca) using a penumbra system red 43 reperfusion catheter (red43), a guidewire, and a neuron max 6f 088 long sheath (neuron max).During the procedure, successful passes were made with the red43 in the target location.The red43 was removed from the patient.The physician noticed a shiny object in the clot on the table and looked at the red43 and noted the distal tip to be fractured.The procedure was completed at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

• Brand Name: PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; a;lameda, CA 94502 ; 5107483200
• MDR Report Key: 22077298
• Report Number: 3005168196-2025-00175
• Device Sequence Number: 9363574
• Product Code: NRY
• UDI-Device Identifier: 00815948025738
• UDI-Public: 00815948025738
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K222808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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 Catalogue Number: RED43138
• Device Lot Number: C00016590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female