BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROMAX ULTRA¿ KIT

    MDR report key: 2173079 · Received July 23, 2011

    Report

    Report Number
    3005099803-2011-02352
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING RELATED POTENTIAL CAUSE FOR THIS EVENT. THE RETURNED DEVICE WAS RECEIVED WITH THE BALLOON DEFLATED. VISUAL AND TACTILE EXAMINATION OF THE DEVICE REVEALED THAT THE BALLOON MATERIAL WAS TORN LONGITUDINALLY AND THAT THE CATHETER SHAFT HAD SEVERAL KINKS ALONG ITS LENGTH. OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON DILATATION CATHETER WAS USED DURING A CYSTOSCOPY BIOPSY FOR THE BLADDER. THE PATIENT AGE WAS REPORTED TO BE OVER 18 YEARS. ACCORDING TO THE COMPLAINANT, THE BALLOON BEGAN TO LEAK ON ITS FIRST INFLATION AFTER IT HAD BEEN FULLY DILATED. A MIXTURE OF CONTRAST AND WATER WAS USED TO INFLATE THE BALLOON, BUT THE EXACT INFLATION PRESSURE OF THE BALLOON AT THE START OF THE LEAK IS UNKNOWN. AFTER THE LEAK WAS NOTICED, THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT. NO PIECES OF THE BALLOON OR BALLOON CATHETER DETACHED INSIDE THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER UROMAX ULTRA BALLOON DILATATION CATHETER WITH NO PATIENT COMPLICATIONS. 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 A CYSTOSCOPY BIOPSY FOR THE BLADDER. THE PATIENT AGE WAS REPORTED TO BE OVER 18 YEARS. ACCORDING TO THE COMPLAINANT, THE BALLOON BEGAN TO LEAK ON ITS FIRST INFLATION AFTER IT HAD BEEN FULLY DILATED. A MIXTURE OF CONTRAST AND WATER WAS USED TO INFLATE THE BALLOON, BUT THE EXACT INFLATION PRESSURE OF THE BALLOON AT THE START OF THE LEAK IS UNKNOWN. AFTER THE LEAK WAS NOTICED, THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT. NO PIECES OF THE BALLOON OR BALLOON CATHETER DETACHED INSIDE THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER UROMAX ULTRA BALLOON DILATATION CATHETER WITH NO PATIENT COMPLICATIONS. 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 UROMAX ULTRA¿ KIT DILATOR, CATHETER, URETERAL EZN BOSTON SCIENTIFIC - GALWAY M0062251220 14199245

    Patients

    Seq Age Sex Outcome Treatment
    1