BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC / MEDITECH

    MDR report key: 489386 · Received October 8, 2003

    Report

    Report Number
    489386
    Event Type
    Death
    Date Received
    October 8, 2003
    Date of Event
    September 16, 2003
    Report Date
    September 22, 2003
    Manufacturer
    BOSTON SCIENTIFIC CORP HEADQTR.
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IVC FILTER WAS INADVERTENTLY PULLED INTO RIGHT SUBCLAVIAN VEIN BY GUIDEWIRE. IVC FILTER IN INCORRECT LOCATION. REMOVED IVC FILTER USING ENDOVASCULAR TECHNIQUES. SEVERE VASCULAR INJURY OCCURRED DURING REMOVAL OF MALPOSITIONED IVC FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC / MEDITECH STAINLESS STEEL GREENFIELD IVC FILTER DTK BOSTON SCIENTIFIC CORP HEADQTR. 50-501 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death