BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIVEWIRE EP CATHETER 7F, DUO DECA, SUPER LRG CURL

    MDR report key: 492562 · Received October 30, 2003

    Report

    Report Number
    2182269-2003-00145
    Event Type
    Other
    Date Received
    October 30, 2003
    Date of Event
    October 1, 2003
    Report Date
    October 30, 2003
    Manufacturer
    ST. JUDE MEDICAL, DAIG DIV INC.
    Product Code
    DRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING PLACEMENT OF THE LIVEWIRE CATHETER IN THE RIGHT ATRIUM, THE CATHETER REMAINED IN A CURVED POSITION AND COULD NOT BE DEFLECTED BACK TO A STRAIGHT POSITION FOR REMOVAL THROUGH THE INFERIOR VENA CAVA. TO RESOLVE THE SITUATION, THE CATHETER WAS CUT DISTAL TO THE HANDLE ASSEMBLY; A LONG INTRODUCER WAS ADVANCED OVER THE CATHETER AND THE DEVICE WAS SUCCESSFULLY REMOVED. THERE WERE NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVEWIRE EP CATHETER 7F, DUO DECA, SUPER LRG CURL LIVEWIRE EP 7F, DUO DECA DRA ST. JUDE MEDICAL, DAIG DIV INC. NA 1013089

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention