BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLOGICAL BALLOON DILATATION CATHETER

    MDR report key: 1897019 · Received November 11, 2010

    Report

    Report Number
    3005099803-2010-04629
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND TACTILE EVALUATION OF THE RETURNED DEVICE REVEALED NO DAMAGE TO THE SHAFT OF THE DEVICE. A FUNCTIONAL EVALUATION OF THE DEVICE REVEALED A LEAK IN THE BALLOON WHEN IT WAS ATTACHED TO AN ENCORE INFLATION UNIT AND WAS INFLATED TO ITS RATED BURST PRESSURE (RBP). MICROSCOPIC EVALUATION OF THE BALLOON REVEALED A LONGITUDINAL TEAR 6MM PROXIMAL TO THE TIP OF THE DEVICE AND WHICH EXTENDED 42MM PROXIMALLY. SEVERAL SCRATCHES WERE ALSO NOTED ON THE BALLOON MATERIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON DILATATION CATHETER WAS USED DURING AN UNKNOWN PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON RUPTURED DURING INFLATION. THE BALLOON WAS INFLATED WITH 4 CC OF CONTRAST SOLUTION AT THE TIME OF THE FAILURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON DILATATION CATHETER WAS USED DURING AN UNKNOWN PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON RUPTURED DURING INFLATION. THE BALLOON WAS INFLATED WITH 4 CC OF CONTRAST SOLUTION AT THE TIME OF THE FAILURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROLOGICAL BALLOON DILATATION CATHETER DILATOR, CATHETER, URETERAL EZN BOSTON SCIENTIFIC - GALWAY M0062251200 13731513

    Patients

    Seq Age Sex Outcome Treatment
    1