BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPID EXCHANGE BILIARY STENT SYSTEM

    MDR report key: 1192129 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05113
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 12, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE STENT REMAINS IMPLANTED, AND THE DELIVERY SYSTEM WAS DISPOSED OF AT THE USER FACILITY, AND WILL NOT BE RETURNED FOR EVAL, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY (ERCP) PROCEDURE, A PIECE OF THE DEVICE BROKE AND REMAINED INSIDE THE PT. THE LESION WAS LOCATED IN AN UNSPECIFIED BILE DUCT. THE RX 7 X 12CM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION, HOWEVER, AT AN UNSPECIFIED TIME DURING THE PROCEDURE, THE INTRODUCER TO THE STENT BROKE OFF AND WAS "UNKNOWINGLY" LEFT INSIDE THE PT. AT AN UNSPECIFIED TIME POST PROCEDURE, THE PT PRESENTED WITH ABDOMINAL PAIN AND UNDERWENT A CT SCAN WHICH REVEALED THAT THE RETAINED PIECE OF THE DEVICE REMAINED IN THE BILE DUCT AND HAD CAUSED A HEMATOMA ON THE "CASTLE" OF THE LIVER. THE PHYSICIAN ELECTED NOT TO INTERVENE DUE TO THE PATIENT'S TERMINAL CANCER. IT WAS FURTHER NOTED THAT THE HEMATOMA IS REDUCING AND THE PT IS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID EXCHANGE BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC M00545580

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other