BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK HEAVYWEIGHT GUIDE WIRE

    MDR report key: 784142 · Received November 9, 2006

    Report

    Report Number
    2124215-2006-18003
    Event Type
    Injury
    Date Received
    November 9, 2006
    Date of Event
    September 6, 2006
    Report Date
    September 6, 2006
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THE 4517 LEFT VENTRICULAR LEAD, THE PHYSICIAN WAS MANEUVERING THE GUIDEWIRE (BHW REF. 1000462HG LOT NUMBER 6052471) TO ADVANCE THE LEAD FORWARD AND THE GUIDE WIRE BROKE IN TWO. THE PROXIMAL PORTION REMAINED IN THE PHYSICIAN'S HAND AND THE DISTAL PORTION REMAINED IN THE LEAD WITHIN THE VESSEL. THE PHYSICIAN WAS ABLE TO REMOVE THE DISTAL PART OF THE GUIDEWIRE WITH THE LEAD. THE LEAD WAS SUCCESSFULLY IMPLANTED. BOTH THE PROXIMAL PORTIONS AND DISTAL PORTIONS OF THE GUIDE WIRE WILL BE RETURNED FOR THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK HEAVYWEIGHT GUIDE WIRE GUIDE WIRE DTB CARDIAC PACEMAKERS 6722 6052471

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention