BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLOGICAL BALLOON DILATATION CATHETER

    MDR report key: 1935932 · Received December 22, 2010

    Report

    Report Number
    3005099803-2010-05164
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE UROMAX ULTRA BALLOON DILATATION CATHETER WAS RETURNED WITH THE BALLOON FOLDED BUT NOT FULLY WRAPPED AROUND THE SHAFT OF THE DEVICE AND THERE WERE TRACES OF DRIED CONTRAST MEDIA PRESENT INSIDE THE BALLOON. A VISUAL AND TACTILE EXAMINATION OF THE DEVICE REVEALED NO DAMAGE TO THE SHAFT OF THE DEVICE. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATOR AND THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE (RBP) AND A LEAK WAS NOTED. MICROSCOPIC EXAMINATION OF THE BALLOON THEN REVEALED A LONGITUDINAL TEAR 35 MM LONG, LOCATED 3 MM PROXIMAL TO THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. SEVERAL SCRATCHES WERE ALSO NOTED ON THE BALLOON MATERIAL FROM THE CENTER OF THE BALLOON TO THE PROXIMAL MARKERBAND. NO OTHER DEFECTS WERE NOTED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON DILATATION CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. THE PATIENT AGE WAS REPORTED TO BE OVER (B)(6). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BALLOON ANTEGRADE INTO THE URETER THROUGH THE KIDNEY. WHEN THE BALLOON WAS INFLATED USING THE ENCORE INFLATION DEVICE, THE BALLOON "POPPED" WITHIN THE URETER. IT IS UNKNOWN TO WHAT DIAMETER THE BALLOON WAS INFLATED. IT WAS REPORTED THAT THE BALLOON REMAINED COMPLETELY IN TACT AND WAS REMOVED FROM THE PATIENT. DILATATION WITH A SECOND BALLOON WAS NOT ATTEMPTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON DILATATION CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. THE PATIENT AGE WAS REPORTED TO BE OVER 18 YEARS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BALLOON ANTEGRADE INTO THE URETER THROUGH THE KIDNEY. WHEN THE BALLOON WAS INFLATED USING THE ENCORE INFLATION DEVICE, THE BALLOON "POPPED" WITHIN THE URETER. IT IS UNKNOWN TO WHAT DIAMETER THE BALLOON WAS INFLATED. IT WAS REPORTED THAT THE BALLOON REMAINED COMPLETELY IN TACT AND WAS REMOVED FROM THE PATIENT. DILATATION WITH A SECOND BALLOON WAS NOT ATTEMPTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROLOGICAL BALLOON DILATATION CATHETER DILATOR, CATHETER, URETERAL EZN BOSTON SCIENTIFIC - GALWAY M0062251000 0013277674

    Patients

    Seq Age Sex Outcome Treatment
    1