BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE BILIARY STENT SYSTEM

    MDR report key: 1162195 · Received September 16, 2008

    Report

    Report Number
    3005099803-2008-04599
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION WAS IN THE COMMON BILE DUCT (CBD). WHILE ATTEMPTING TO ADVANCE A 7 X 12CM RX STENT OVER AN UNSPECIFIED TYPE OF GUIDE WIRE, THE "INTERNAL WIRE, THAT PULLS THE INTRODUCER BACK, POPPED OUT OF THE SIDE PORT". THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID EXCHANGE BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC M00545580 11735222

    Patients

    Seq Age Sex Outcome Treatment
    1