BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPID EXCHANGE BILIARY STENT SYSTEM

    MDR report key: 1132612 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03136
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, A DETACHMENT OCCURRED. THE TARGET LESION WAS IN THE COMMON BILE DUCT. A 10 X 10CM RX BILIARY STENT HAD BEEN SELECTED AND ADVANCED THROUGH AN UNSPECIFIED SCOPE. AT AN UNSPECIFIED TIME DURING THE PROCEDURE, THE INTRODUCER "DISENGAGED FROM THE CATHETER AND GOT STUCK IN THE SCOPE." THE PHYSICIAN WAS UNABLE TO REWIRE THE TARGET LESION. THE PROCEDURE WAS ABORTED AND THE PT RETURNED THE FOLLOWING DAY FOR ANOTHER ERCP PROCEDURE WITH ANOTHER PHYSICIAN. THERE WERE NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID EXCHANGE BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC M00545620 8156360

    Patients

    Seq Age Sex Outcome Treatment
    1 Other