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	03/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left m1 segment of the middle cerebral artery (mca) using a penumbra system red 68 reperfusion catheter (red68) and a neuron max 6f 088 long sheath (neuron max).The physician performed one pass in the target location using the red68.After removing the red68 from the patient, the physician found that it was fractured on the distal length.Therefore, the red68 was no longer used in the procedure.The procedure was completed using a new red68 and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned penumbra system red 68 reperfusion catheter (red68) confirmed a fracture on the distal shaft.Based on the reported complaint, the red68 likely fractured due to a kink upon retraction after completion of one pass.If the red68 is retracted at an angle during removal from the patient, damage such as a kink and fracture may occur.The root cause could not be determined.Further evaluation of the red68 revealed an additional damage consisting of fractures, ovalizations and kinks on its distal length.This damage likely occurred during packaging for return and was incidental to the reported complaint.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 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: 25222812
• Report Number: 3005168196-2026-00169
• Device Sequence Number: 9792189
• Product Code: NRY
• UDI-Device Identifier: 00815948024113
• UDI-Public: 00815948024113
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: H00008701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/19/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male