MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (SILVER); NRY

Catalog Number	RED72KIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned penumbra system red 72 silver reperfusion catheter (red72 silver) confirmed the catheter was fractured.Evaluation revealed stretching and ovalization throughout the distal length.This indicates that the device likely stretched prior to fracturing.If the device is retracted against resistance, damage such as stretching and subsequent fractures may occur.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed kinks and an additional fracture.This damage was likely incidental to the complaint and may have occurred during removal from the patient.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 right m1 segment of the middle cerebral artery (mca) using a penumbra system red 72 silver reperfusion catheter (red72 silver), a non-penumbra sheath (7f), a non-penumbra microcatheter, and a guidewire.The red72 silver was successfully used to complete the procedure.While removing the red72 silver from the patient it was noticed under fluoroscopy that the catheter fractured.A snare device was used to remove the red72 silver from the patient.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (SILVER)
• 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 menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 25685207
• Report Number: 3005168196-2026-00222
• Device Sequence Number: 9656561
• Product Code: NRY
• UDI-Device Identifier: 00815948029989
• UDI-Public: 00815948029989
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K242104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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: RED72KIT
• Device Lot Number: F00017795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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: 38 YR
• Patient Sex: Female