BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROMAX ULTRA BALLOON CATHETER 10CC KIT

    MDR report key: 1171328 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04636
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A CYSTO PROCEDURE THE BALLOON "BROKE". A UROMAX ULTRA BALLOON CATHETER HAD BEEN ADVANCED TO AN UNSPECIFIED LOCATION. WHILE ATTEMPTING TO INFLATE THE BALLOON CATHETER, WITH THE INFLATION DEVICE INCLUDED IN THE KIT, THE BALLOON "BROKE". THE PROCEDURE WAS DELAYED 5 MINUTES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROMAX ULTRA BALLOON CATHETER 10CC KIT EZN BOSTON SCIENTIFIC M0062251370 11657215

    Patients

    Seq Age Sex Outcome Treatment
    1