BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL MANDREL

    MDR report key: 5515908 · Received January 11, 2016

    Report

    Report Number
    5515908
    Event Type
    Malfunction
    Date Received
    January 11, 2016
    Date of Event
    December 1, 2015
    Report Date
    December 17, 2015
    Manufacturer
    VASCULAR SOLUTIONS
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING RFA OF RIGHT RGSV, THE GUIDEWIRE GOT STUCK IN THE CATHETER. WHILE REMOVING CATH AND THE TIP OF THE WIRE BROKE OFF IN THE VEIN (1-2MM PIECE). VEIN ABLATION WAS SUCCESSFUL. DURING RADIOFREQUENCY ABLATION OF RIGHT GREATER SAPHENOUS VEIN, THE GUIDEWIRE GOT STUCK IN THE CATHETER. WHILE REMOVING CATHETER THE TIP OF THE WIRE BROKE OFF IN THE VEIN (1-2MM PIECE) AT THE VALVE IN RIGHT MID SFV. VEIN ABLATION WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18454 NITINOL MANDREL GUIDEWIRE DQX VASCULAR SOLUTIONS 586736

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR