BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA BILIARY STENT SYSTEM

    MDR report key: 1143688 · Received August 29, 2008

    Report

    Report Number
    3005099803-2008-04183
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Adverse Event
    Yes
    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 A BILIARY STENTING TREATMENT PROCEDURE, A SHAFT BREAK WITH PREMATURE STENT DEPLOYMENT OCCURRED. A 7FR/7CM BILIARY STENT HAD BEEN ADVANCED TO AN UNSPECIFIED BILIARY LOCATION. WHILE ATTEMPTING TO DEPLOY THE DEVICE, THE PHYSICIAN ENCOUNTERED RESISTANCE. THE PHYSICIAN CONTINUED TO RETRACT THE INNER CATHETER TO DEPLOY THE STENT WHEN THE INNER CATHETER BECAME "TORN". THE PHYSICIAN ATTEMPTED TO "RETRIEVE" THE DEVICE FROM THE UNSPECIFIED TYPE SCOPE, AND THE STENT "RELEASED" FROM THE PUSH CATHETER AND WAS LODGED IN THE SCOPE CHANNEL. THE STENT WAS ABLE TO BE RETRIEVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED TYPE OF DIFFERENT DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC M00539210 9026581

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R