BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA BILIARY STENT

    MDR report key: 1150257 · Received September 3, 2008

    Report

    Report Number
    3005099803-2008-04303
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K023870
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND REVEALED NO RELATED ISSUES TO THIS COMPLAINT. THERE IS NOT ENOUGH INFO PER THE EVENT DESCRIPTION OR FROM SIMILAR COMPLAINT INVESTIGATIONS TO PROVIDE A MOST PROBABLE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THE BILIARY STENT "FOLDED" WHILE BEING INTRODUCED. THE PHYSICIAN INTRODUCED THE BILIARY STENT AND THE STENT REPORTEDLY "FOLDED" WHILE INTRODUCING. THE PHYSICIAN REMOVED THE DEVICE AND COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. THE PT WAS REPORTED TO BE STABLE POST PROCEDURE WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY STENT FGE BOSTON SCIENTIFIC CORPORATION M00539220 11113122

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention