BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK WHISPER MS-J GUIDE WIRE

    MDR report key: 606185 · Received February 10, 2005

    Report

    Report Number
    2124215-2005-09197
    Event Type
    Malfunction
    Date Received
    February 10, 2005
    Date of Event
    November 5, 2004
    Report Date
    November 5, 2004
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT WHILE ATTEMPTING TO IMPLANT THIS LEFT VENTRICULAR LEAD, THE WHISPER GUIDEWIRE'S TIP BROKE OFF INSIDE THE LUMEN DURING THE WIRE EXCHANGE. A NEW WIRE WAS THEN INSERTED INTO THE LEAD; HOWEVER, THE WIRE WAS UNABLE TO BE ADVANCED. THE LEAD WAS WITHDRAWN FROM THE PATIENT AND FLUSHED, WHICH AT THAT POINT, THE WIRE TIP WAS EXPELLED FROM THE LEAD. THE LEAD WAS REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK WHISPER MS-J GUIDE WIRE GUIDE WIRE DTB CARDIAC PACEMAKERS 6738 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other