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	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned penumbra system red 68 reperfusion catheter (red68) confirmed that the catheter was fractured.The fracture is likely a result of kink.This type of damage such as a kink and subsequent fracture typically occurs if the red68 is manipulated against resistance during use.The reported tortuous patient's anatomy may have contributed to resistance during the procedure.Further evaluation revealed kinks along the catheter shaft and an ovalization on the distal tip.This damage was incidental to the reported complaint.The kinks along the distal shaft and ovalized distal tip may have occurred due to advancement against resistance.The kinks along the proximal shaft may have occurred during packaging for return to penumbra.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 m1 segment of the middle cerebral artery (mca) using a penumbra system red 68 reperfusion catheter (red68), a penumbra system red 43 reperfusion catheter (red43), and a neuron max 6f 088 long sheath (neuron max).It should be noted that the patient's anatomy was tortuous and the patient had intracranial atherosclerosis (icas).During the procedure, the physician completed one pass using the red68.It was reported that all of the thrombus was successfully removed.While removing the red68, the midshaft of the red68 was noticed to be fractured.The red68 was removed from the patient in its entirety.The procedure was completed at this point.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: 24396962
• Report Number: 3005168196-2026-00051
• Device Sequence Number: 18287536
• Product Code: NRY
• UDI-Device Identifier: 00815948024113
• UDI-Public: 00815948024113
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/19/2026

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: C00020038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/19/2026
• 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: 60 YR
• Patient Sex: Male