BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROMAX ULTRA BALLOON DILATATION CATHETER

    MDR report key: 3112161 · Received September 21, 2006

    Report

    Report Number
    6000111-2006-00023
    Event Type
    Malfunction
    Date Received
    September 21, 2006
    Date of Event
    August 30, 2006
    Report Date
    August 31, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS CURRENTLY BEING EVALUATED BY THIS MFR. FOLLOWING COMPLETION OF THE ENGINEERING EVAL, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FORWARDED UNDER THE APPROPRIATE SEQUENCE NUMBER. PER F/U WITH THE CUSTOMER, THE BURST BALLOON WAS WITHDRAWN CAUSING NO PT COMPLICATIONS. OUR DIRECTIONS FOR USE STATE: "CAUTION: INFLATION SYRINGES ARE CAPABLE OF ATTAINING VERY HIGH PRESSURE WITH MINIMAL EFFORT. NOTE: THE RECOMMENDED BALLOON INFLATION PRESSURE SHOULD NOT BE EXCEEDED. REFER TO PRODUCT LABEL FOR RECOMMENDED INFLATION PRESSURES. INFLATION IN EXCESS OF RECOMMENDED PRESSURE RATINGS MAY CAUSE ANY BALLOON TO RUPTURE." WE ARE UNABLE AT THIS TIME OF THIS FILING TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THERAPEUTIC URETEROSCOPY THIS BALLOON CATHETER BURST. THE CATHETER WAS WITHDRAWN AND THE CASE WAS COMPLETELY SUCCESSFULLY WITH NO PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROMAX ULTRA BALLOON DILATATION CATHETER URETERAL DILATATION EZN BOSTON SCIENTIFIC NA 8026728

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK