BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 638009 · Received February 9, 2004

    Report

    Report Number
    2124215-2004-06891
    Event Type
    Malfunction
    Date Received
    February 9, 2004
    Date of Event
    December 22, 2003
    Report Date
    December 22, 2003
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS GUIDEWIRE TIP, LOT 2091672 REFERENCE NUMBER 1001782, BROKE OFF IN THE CORONARY SINUS, DISTAL TO THE LEAD, DURING THE IMPLANTATION OF A COMPETITIVE CORONARY SINUS LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK MIDDLEWEIGHT GUIDE WIRE GUIDE WIRE DTB CARDIAC PACEMAKERS 6720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other