BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUIDANT MS WHISPER

    MDR report key: 822467 · Received February 26, 2007

    Report

    Report Number
    MW1042045
    Event Type
    Other
    Date Received
    February 26, 2007
    Date of Event
    January 31, 2007
    Manufacturer
    GUIDANT CARDIAC & VASCULAR GRP
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE WAS FOR A BIVENTRICULAR PACING ICD IMPLANT. DURING POSITIONING OF THE LV LEAD, THE ANGIOPLASTY GUIDEWIRE WAS MANEUVERED IN THE CORONARY SINUS TRIBUTARY. THE DISTAL PART OF THE GUIDEWIRE FRACTURED AND THE END OF THE GUIDEWIRE RETAINED IN THE ANTERIOR INTRAVENTRICULAR VENOUS BRANCH. CAUSE OF BREAKAGE WAS MOST LIKELY MATERIAL PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT MS WHISPER ANGIOPLASTY GUIDEWIRE DQX GUIDANT CARDIAC & VASCULAR GRP MS WHISPER 6111152

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other