BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUFLEX URETERAL STENT

    MDR report key: 646395 · Received September 28, 2005

    Report

    Report Number
    6000043-2005-00061
    Event Type
    Malfunction
    Date Received
    September 28, 2005
    Date of Event
    March 22, 2005
    Report Date
    March 24, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING DEPLOYMENT OF THIS STENT IN A THERAPEUTIC UROLOGICAL PROCEDURE, ONE OF THE COILS BROKE OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER STENT WITH NO PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUFLEX URETERAL STENT URETERAL STENTS FAD BOSTON SCIENTIFIC NA 0007209746

    Patients

    Seq Age Sex Outcome Treatment
    1 NA