BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADIAL JAW 3

    MDR report key: 865961 · Received June 14, 2007

    Report

    Report Number
    865961
    Event Type
    Death
    Date Received
    June 14, 2007
    Date of Event
    May 2, 2007
    Report Date
    May 29, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS SCHEDULED FOR A FIBEROPTIC BRONCHOSCOPY OF A LARGE RIGHT HILAR MASS, SUSPECTED TO BE BRONCHOGENIC CARCINOMA. A TRANSBRONCHIAL BIOPSY WAS ATTEMPTED AT THE RIGHT UPPER LOBE POSTERIOR SEGMENT. WITH THE FIRST TRANSBRONCHIAL BIOPSY, A GUSH OF BLEEDING OCCURRED WHICH FAILED TO STOP DESPITE TAMPONADING OF THE BLEEDING SITE WITH THE TIP OF THE SCOPE AND ADMINISTRATION OF 4ML OF 1/10,000 EPINEPHRINE SOLUTION. BLEEDING CONTINUED, PT WAS CODED AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 PULMONARY WITH NEEDLE FCL BOSTON SCIENTIFIC CORPORATION RADIAL JAW 3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death