BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPID EXCHANGE BILIARY STENT SYSTEM

    MDR report key: 1180179 · Received September 29, 2008

    Report

    Report Number
    3005099803-2008-04826
    Event Type
    Injury
    Date Received
    September 29, 2008
    Report Date
    September 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF THE RX BILIARY STENT, THE WIRE WOULD NOT EXIT THE SIDE HOLE OF THE STENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1