BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROVASIVE RAPID EXCHANGE BILIARY STENT SYSTEM

    MDR report key: 1933924 · Received December 15, 2010

    Report

    Report Number
    MW5018635
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ERCP PERFORMED. A 7 FR - 10 CM BILIARY STENT WAS INSERTED INTO THE SCOPE. ATTEMPTED TO DEPLOY THE STENT WHEN THE SHEATH WOULD NOT ADVANCE OR COULD NOT BE REMOVED FROM THE SCOPE. THE ENTIRE SYSTEM WAS REMOVED FROM THE PT. ONCE SYSTEM OUT OF PT, THE SHEATH WAS REMOVED AND IT WAS NOTED THAT IT HAD BEEN SHEARED IN HALF AT APPROXIMATELY THE SIDE PORT AREA. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVASIVE RAPID EXCHANGE BILIARY STENT SYSTEM BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC 4557 11466400

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR