BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROMAX ULTRA BALLOON DILATION CATHETER

    MDR report key: 1140701 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04151
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 31, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A UROLOGY TREATMENT PROCEDURE, A BALLOON LEAK OCCURRED. THE TARGET LESION WAS IN AN UNSPECIFIED URETERAL LOCATION. A 8/75 10 CC LIWG KIT HAD BEEN SELECTED TO TREAT THE TARGET LESION. THE BALLOON CATHETER HAD BEEN ADVANCED TO THE TARGET LESION. WHILE ATTEMPTING TO INFLATE THE BALLOON WITH THE INFLATION DEVICE CONTAINED IN THE KIT, IT WAS NOTICED THAT THE BALLOON LEAKED CONTRAST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROMAX ULTRA BALLOON DILATION CATHETER EZN BOSTON SCIENTIFIC M0062251270 0011299268

    Patients

    Seq Age Sex Outcome Treatment
    1