BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEIN360 ENDOVENOUS RADIOFREQUENCY ABLATION (RFA) CATHETER

    MDR report key: 24048027 · Received January 12, 2026

    Report

    Report Number
    3015988948-2026-00001
    Event Type
    Injury
    Date Received
    January 12, 2026
    Date of Event
    December 10, 2025
    Report Date
    January 12, 2026
    Manufacturer
    VEIN360, LLC
    Product Code
    NUJ
    UDI-DI
    0086003600555
    PMA / PMN Number
    K191073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    DURING THE TREATMENT OF AN EXTREMELY TORTUOUS VEIN, THE PHYSICIAN WAS ABLE TO ADVANCE THE CATHETER TIP TO THE SAPHENOFEMORAL JUNCTION. THE DEVICE FUNCTIONED NORMALLY DURING THE FIRST SEVERAL TREATMENT CYCLES. AS THE PHYSICIAN CONTINUED TO WITHDRAW THE CATHETER, IT FAILED TO REACH TEMPERATURE. WHEN THE PHYSICIAN ATTEMPTED TO WITHDRAW THE CATHETER, HE NOTED RESISTANCE AND THE DEVICE APPEARED TO BE STUCK WITHIN THE VEIN. THE PHYSICIAN APPLIED ADDITIONAL TRACTION AND WAS ABLE TO REMOVE THE CATHETER, BUT OBSERVED THAT THE DISTAL PORTION, INCLUDING THE HEATING ELEMENT, HAD SEPARATED AND WAS RETAINED IN THE SAPHENOUS VEIN. THE PHYSICIAN SUBSEQUENTLY PERFORMED INTRAVASCULAR ULTRASOUND AND VENOGRAPHY OF THE SAPHENOUS VEIN. THE PHYSICIAN PLACED EMBOLIZATION COILS PROXIMAL AND DISTAL TO THE RETAINED CATHETER FRAGMENT TO PREVENT MIGRATION/EMBOLIZATION. THE PATIENT WAS DISCHARGED THE SAME DAY AND HAS BEEN SEE IN FOLLOW-UP. THE PATIENT HAS REPORTED NO SYMPTOMS RELATED TO THE COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109568 VEIN360 ENDOVENOUS RADIOFREQUENCY ABLATION (RFA) CATHETER ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, REPROCESSED NUJ VEIN360, LLC CF7-7-100 0086003600555

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention