BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX WALLSTENT BILIARY ENDOPROSTHESIS

    MDR report key: 810485 · Received January 29, 2007

    Report

    Report Number
    6000050-2007-00005
    Event Type
    Injury
    Date Received
    January 29, 2007
    Date of Event
    January 15, 2007
    Report Date
    January 17, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    FGE
    PMA / PMN Number
    k012752
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN REC'D BY THIS MFR. AN EVAL HAS NOT BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT DURING A THERAPEUTIC PLACEMENT OF A RX WALLSTENT BILIARY ENDOPROSTHESIS (PT AGE AND GENDER UNK), THE DELIVERY CATHETER DETACHED DURING THE STENT DEPLOYMENT. THE PHYSICIAN USED A SNARE TO RETRIEVE THE DEVICE AND ANOTHER STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PT'S CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX WALLSTENT BILIARY ENDOPROSTHESIS FGE FGE BOSTON SCIENTIFIC CORP M00569650 9022815

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention