BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROMAX ULTRA BALLOON DILATION CATHETER

    MDR report key: 1190827 · Received September 24, 2008

    Report

    Report Number
    3005099803-2008-04793
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 29, 2008
    Report Date
    August 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE UROMAX ULTRA BALLOON HAD A LEAK. THE LEAK WAS FOUND WHEN THE DEVICE WAS ATTEMPTED TO BE INFLATED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS REPORTED TO BE FINE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROMAX ULTRA BALLOON DILATION CATHETER EZN - URETERAL DILATATION EZN BOSTON SCIENTIFIC CORPORATION M0062251220 0011020023

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR