MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER; NRY

Catalog Number	RED68KIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned penumbra system red68 reperfusion catheter (red68) confirmed that the catheter was fractured.If the red68 is advanced against resistance, damage such as a kink may occur.Subsequent retraction of a kink device may worsen to the fracture.Based on the reported event, the root cause of resistance could not be determined.Penumbra devices are visually 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 middle cerebral artery (mca) using a penumbra system red 43/62/68/72 reperfusion catheter (red43, red62, red68, red72), a benchmark bmx96 access system (bmx96), and a microwire.It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician attempted to advance a red43 with a red72, red62, and a microwire, however, the devices could not be advanced due to the patient¿s anatomy.The physician then attempted to readvance the red43 with a red68 to the target location, but the red68 and the red43 would not advance.The physician decided to remove the catheters by removing the red43 first.While removing the red68, it fractured at the distal end.The physician then removed the red68 by hand.No portion of the red68 was in the patient's body.The physician attempted to use non-penumbra catheters; however, the catheters would not advance due to the patient¿s anatomy.The procedure was aborted.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM RED 68 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: 24837562
• Report Number: 3005168196-2026-00110
• Device Sequence Number: 9158816
• Product Code: NRY
• UDI-Device Identifier: 00815948024113
• UDI-Public: 00815948024113
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K211411
• 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): 04/09/2026

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: RED68KIT
• Device Lot Number: H00008702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown