BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVE MAPPER STEEROCATH-DX MAPPING CATHETER

    MDR report key: 511439 · Received January 16, 2004

    Report

    Report Number
    2939222-2004-00003
    Event Type
    Malfunction
    Date Received
    January 16, 2004
    Date of Event
    August 11, 2003
    Report Date
    August 12, 2003
    Manufacturer
    EP TECHNOLOGIES, INC.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER COMPLAINED OF A "CORKSCREWED" CATHETER, WITH NO PT INJURY. INITIAL EXAM CONFIRMED THE COMPLAINT. UPON FURTHER EVAL AND INVESTIGATION OF SIMILAR COMPLAINTS, IT WAS DETERMINED IN 2003 THIS FAILURE COULD LEAD TO THE PROTRUSION OF A WIRE FROM THE STEERING MECHANISM ASSEMBLY WITH POTENTIAL FOR INJURY TO THE PT. THE CAUSE OF THE FAILURE IS UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALVE MAPPER STEEROCATH-DX MAPPING CATHETER THERAPEUTIC ABLATION CATHETER DRF EP TECHNOLOGIES, INC. 2270N4 4671277

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN