BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA BILIARY STENT SYSTEM

    MDR report key: 1181184 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04925
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 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 AN UNSPECIFIED STENTING PROCEDURE, RESISTANCE WAS ENCOUNTERED AND A SHEATH FRACTURE OCCURRED. THE LESION WAS LOCATED IN AN UNSPECIFIED BILE DUCT. THE 8.5FR/10CM FLEXIMA BILIARY STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. RESISTANCE WAS ENCOUNTERED UPON RETRACTING THE INNER SHEATH TO RELEASE THE STENT. THE PHYSICIAN ATTEMPTED TO RETRACT THE SHEATH MORE SLOWLY TO RELEASE THE STENT; HOWEVER, THE INNER SHEATH FRACTURED AND REMAINED INSIDE THE STENT. THE SDS WAS REMOVED AND THE PHYSICIAN WAS ABLE TO RETRIEVE THE STENT UTILIZING A FORCEPS. THE PHYSICIAN CANNULATED THE DUCT BY UNSPECIFIED MEANS AND PLACED AN UNSPECIFIED ENDOSCOPIC BILIARY DRAINAGE (EBD) TUBE TO COMPLETE THE PROCEDURE. THE PATIENT'S STATUS IS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC M00539270 11055127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 260V ENDOSCOPE