MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER; NRY

Catalog Number	RED72
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system red 72 reperfusion catheter (red72).During the procedure, the red72 fractured during removal after the first pass.No additional information was provided.The procedure was completed using a new catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided; therefore, the manufacturing records could not be reviewed.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed and on the initial mfr report and is being corrected on this follow-up mfr report: 1.Section h box 10.Related report numbers.

• Brand Name: PENUMBRA SYSTEM RED 72 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 menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 24630437
• Report Number: 3005168196-2026-00085
• Device Sequence Number: 8985420
• Product Code: NRY
• UDI-Device Identifier: 00815948029972
• UDI-Public: 00815948029972
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K211654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: RED72
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown