BEUDAMED
    FDA Adverse Event Summary report: N

    EXPRESS BILIARY SD MONORAIL PREMOUNT STENT SYSTEM

    MDR report key: 1032572 · Received April 2, 2008

    Report

    Report Number
    1032572
    Date Received
    April 2, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FGE
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN NOTICED THAT THE 7MM BILIARY SD STENT DID NOT FIT IN THE 6 FR. GUIDE. THE DEVICE WAS REMOVED AND REPLACED WITH A 6 MM BILIARY SD STENT. THE PATIENT WAS NOT HARMED AS A RESULT OF THE ERROR. MANUFACTURER RESPONSE FOR BILIARY SD STENT: THE RESPONSE WAS THAT THE DEVICE WAS USED "OFF LABEL" SO NO FURTHER INVESTIGATION WILL BE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY SD MONORAIL PREMOUNT STENT SYSTEM STENT, BILIARY FGE BOSTON SCIENTIFIC CORP. * 8628079

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR