BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA

    MDR report key: 1131364 · Received August 11, 2008

    Report

    Report Number
    1131364
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A BILIARY TUBE WAS PLACED IN A PATIENT FOR TEMPORARY DRAINAGE OF ASCITES. WHEN THE PHYSICIAN ATTEMPTED TO TAKE OUT THE METAL STIFFENER, IT WAS STUCK IN THE TUBE AND CAUSING THE TUBE TO BUCKLE. ANOTHER CATHETER WAS USED, AND THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA CATHETER, BILIARY FGE BOSTON SCIENTIFIC CORP. CE 0197 11756761

    Patients

    Seq Age Sex Outcome Treatment
    1 *