BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONETOME STONE REMOVAL DEVICE

    MDR report key: 1063577 · Received June 20, 2008

    Report

    Report Number
    3005099803-2008-00874
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Report Date
    May 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND REVEALED NO RELATED ISSUES TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST THE LOT. INVESTIGATION OF THE RETURNED DEVICE NOTED RESIDUE WAS PRESENT ON THE DEVICE INDICATING USE. A VISUAL EVAL FOUND THAT THE WORKING LENGTH WAS KINKED AT THE GREEN BAND NEAR THE PROXIMAL PIERCE HOLE. SINCE THE PRODUCT IS 100% INSPECTED DURING MANUFACTURING, THE KINK IS LIKELY DUE TO THE CUSTOMER USAGE/HANDLING. FROM THE PRODUCT ANALYSIS, IT WAS FOUND THAT A 0.035" GUIDEWIRE COULD NOT BE INSERTED PROXIMALLY THROUGH THE GUIDEWIRE PORT LUER. THE 0.035" GUIDEWIRE COULD BE INSERTED DISTALLY THROUGH THE DISTAL TIP OF THE DEVICE AND ADVANCED THROUGH THE WORKING LENGTH, BUT DOES NOT EXIT OUT OF THE GUIDEWIRE PORT LUER NEAR THE HANDLE. A FUNCTIONAL EVAL FOUND THAT THE DEVICE WOULD BOW PAST 90 DEGREES WHICH MEETS THE BOWING SPECIFICATION OF 90 DEGREE MINIMUM. CUSTOMER COMPLAINT THAT THE GUIDEWIRE FAILED TO RETRACT OUT FROM THE GUIDEWIRE EXIT PORT IS CONFIRMED. THE ROOT CAUSE FOR THIS COMPLAINT IS BEING CLASSIFIED AS MANUFACTURING SINCE AN INCORRECT LUER WAS ASSEMBLED TO THE GUIDEWIRE PORT OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A GUIDEWIRE WAS CROSSED TO THE BILE DUCT AND WAS TRIED TO ADVANCE THROUGH THE LESION, BUT THE GUIDEWIRE FAILED TO COME OUT FROM THE STONETOME STONE REMOVAL DEVICE GUIDEWIRE EXIT PORT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONETOME STONE REMOVAL DEVICE FDI BOSTON SCIENTIFIC CORPORATION M00535110 11521856

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK