BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE BILIARY STENT SYSTEM

    MDR report key: 1213081 · Received October 23, 2008

    Report

    Report Number
    3005099803-2008-05478
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORK, LTD.
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 24, 2008 THAT A RAPID EXCHANGE BILIARY STENT SYSTEM WAS USED SIX DAYS PRIOR. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN EXPERIENCED DIFFICULTLY ADVANCING THE STENT DELIVERY SYSTEM OVER THE GUIDEWIRE. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE (UNKNOWN PRODUCT/MANUFACTURER). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID EXCHANGE BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC CORK, LTD. M00545890 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK