BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEFLECTABLE TIP ELECTROPHYSIOLOGY CATHETER

    MDR report key: 625909 · Received August 3, 2005

    Report

    Report Number
    625909
    Event Type
    Other
    Date Received
    August 3, 2005
    Date of Event
    July 27, 2005
    Report Date
    August 3, 2005
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEW DECAPOLAR CATHETER OPENED AND USED, BUT AFTER ATTEMPTING TO GET INTO THE CS (CORONARY SINUS) AND FAILING, THE PHYSICIAN PULLED THE CATHETER AND DISCOVERED THAT IT HAD SHEARED INTO TWO PIECES. A SECOND CATHETER WAS OPENED AND SUBSTITUTED FOR DEFECTIVE DEVICE. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFLECTABLE TIP ELECTROPHYSIOLOGY CATHETER EP CATHETER DRF BIOSENSE WEBSTER WEBSTER D 13033337

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR