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

Catalog Number	RED72SDKIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right internal carotid artery (ica) using a penumbra system red 72 reperfusion catheter (red72), a non-penumbra sheath, and a guidewire.During the procedure, the physician successfully completed nine passes using the red72.While retracting the red72, the physician noticed under fluoroscopy that the red72 fractured at the distal length and remained in the vessel.Therefore, the physician used a stent retriever to remove the fractured segment of the red72.The procedure was completed using a new red72, the same stent retriever, and the same sheath.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right internal carotid artery (ica) using a penumbra system red 72 reperfusion catheter (red72), a non-penumbra sheath, and a guidewire.During the procedure, the physician successfully completed nine passes using the red72.While retracting the red72, the physician noticed under fluoroscopy that the red72 fractured and remained in the vessel.Therefore, the physician used a stent retriever to remove the fractured segment of the red72.The procedure was completed using a new red72, the same stent retriever, and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated: 1.Section b.Box 5.Describe event or problem evaluation of the returned penumbra system red 72 reperfusion catheter (red72) revealed that the distal tip was damaged, and the markerband was detached.This is likely the reported fracture.The root cause could not be determined.Based on the reported event, the red72 was overused during the procedure.This may have contributed to the distal tip damage and markerband detaching.Further evaluation revealed kinks along the catheter shaft.This damage was likely incidental to the complaint and may have occurred due to extensive use of the device.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 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 21439558
• Report Number: 3005168196-2025-00047
• Device Sequence Number: 14537214
• Product Code: NRY
• UDI-Device Identifier: 00815948025943
• UDI-Public: 00815948025943
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: RED72SDKIT
• Device Lot Number: F00012168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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: Unknown