BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPHROMAX KIT

    MDR report key: 1172912 · Received September 19, 2008

    Report

    Report Number
    3005099803-2008-04731
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZN
    PMA / PMN Number
    K952968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BEEN RETURNED AS IT WAS REPORTED TO BE DISPOSED OF BY THE FACILITY. THEREFORE, DEVICE ANALYSIS CANNOT BE PERFORMED. A DEVICE HISTORY REVIEW INDICATED THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION, THEREFORE, OPERATIONAL CONTEXT IS ASSIGNED AS THE MOST LIKELY ROOT CAUSE OF THIS EVENT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST THE REPORTED LOT NUMBER. THE 15-MONTH PRODUCT FAMILY TRENDING CHART WAS REVIEWED AND DOES NOT INDICATE A NEGATIVE TREND.

    Description of Event or Problem · 1

    A NEPHROMAX KIT WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WOULD NOT MAINTAIN PRESSURE; THERE WAS A LEAK IN THE BALLOON. IT WAS ALSO REPORTED THAT THE BALLOON WAS REMOVED AND A SECOND, SAME TYPE BALLOON, WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED COMPLICATIONS. THE PT WAS REPORTED TO BE "FINE" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPHROMAX KIT EZN BOSTON SCIENTIFIC CORPORATION M0062101180 11818876

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK