BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY STENT

    MDR report key: 1063803 · Received June 18, 2008

    Report

    Report Number
    3005099803-2008-00760
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Report Date
    May 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K023870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE INNER CATHETER DETACHED. THE LOCATION OF THE LESION IS UNK. WHILE ATTEMPTING TO DEPLOY THE FLEXIMA BILIARY 7FR X 10CM STENT, "STRONG RESISTANCE" WAS ENCOUNTERED. UPON REMOVAL OF THE STENT DELIVERY SYSTEM, THE "INNER CATHETER STRETCHED AND DETACHED" OUTSIDE OF THE PT. IT WAS NOT KNOWN IF THE STENT HAD BEEN IMPLANTED. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY STENT FGE BOSTON SCIENTIFIC M00539220

    Patients

    Seq Age Sex Outcome Treatment
    1