BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1181672 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04937
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Report Date
    September 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE THE BASKET "FELL APART." A ZERO TIP KNOT 2.4X4X120 BASKET HAD BEEN ADVANCED TO AN UNSPECIFIED URETERAL LOCATION. AT AN UNSPECIFIED TIME DURING THE PROCEDURE, THE BASKET LOST IT'S SHAPE AND WOULDN'T FUNCTION. THE TORQUE CAP APPEARED SEPARATED FROM THE HANDLE. THE SHEATH ALSO APPEARED KINKED. ALL DEVICE COMPONENTS WERE ACCOUNTED FOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS REPORTED TO E IN GOOD CONDITION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET FFL BOSTON SCIENTIFIC M0063901010 117100734

    Patients

    Seq Age Sex Outcome Treatment
    1