BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARDIS SOFT HYDRO URETERAL STENT WITH GUIDEWIRE

    MDR report key: 1333195 · Received March 5, 2009

    Report

    Report Number
    3005099803-2008-01917
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Date of Event
    October 13, 2005
    Report Date
    October 13, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWS NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. THE DEVICE HAS NOT BEEN RECEIVED BY THIS MANUFACTURER. AN EVALUATION HAS NOT BEEN PERFORMED; THEREFORE A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORT # 3005099803-2008-1547 FOR A DESCRIPTION OF THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT WHILE PREPARING FOR A PROCEDURE USING THE MARDIS SOFT HYDRO URETERAL STENT WITH GUIDEWIRE, IT WAS NOTED THAT THE PRODUCT INFORMATION ON THE STICKER AND STENT DIFFERED FROM THAT INSIDE THE PACKAGING. ACCORDING TO THE CUSTOMER, THE BOX EXTERIOR LOT 0008104023, WHILE THE INTERIOR OF THE BOX LOT 7993118. ADDITIONALLY, THE "NEW" BOXES NO LONGER HAVE "MICROVASIVE" PRINTED ON THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARDIS SOFT HYDRO URETERAL STENT WITH GUIDEWIRE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION-SPENCER M0061254520 7912323

    Patients

    Seq Age Sex Outcome Treatment
    1