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

Catalog Number	RED43160
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system red 43 reperfusion catheter (red43), a penumbra system red 62 reperfusion catheter (red62), and a non-penumbra sheath.During the procedure, the physician advanced the red43 and red62 together into the target location.Next, while removing the red43 out of the red62 and the physician fractured the proximal end of the red43.It was reported that the physician was able to successfully remove the red43.The physician then used the red62 to remove the clot, and procedure was completed at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned penumbra system red 43 reperfusion catheter (red43) confirmed that the proximal end of the catheter was fractured.The complaint indicated that the red43 was fractured during removal from a parent catheter.If red43 is mishandled during retraction, damage such as kink and subsequent fracture may occur.Further evaluation revealed stretching near the distal end of the catheter shaft.This damage was incidental to the reported complaint and likely occurred due to retraction against resistance.Based on the reported complaint, the root cause of the resistance 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.

• 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; alameda, CA 94502 ; 5107483200
• MDR Report Key: 21610026
• Report Number: 3005168196-2025-00080
• Device Sequence Number: 7756348
• Product Code: NRY
• UDI-Device Identifier: 00815948025745
• UDI-Public: 00815948025745
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/07/2025

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: RED43160
• Device Lot Number: F00014397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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 Age: 84 YR
• Patient Sex: Female