BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UROMAX ULTRA?

    MDR report key: 3812163 · Received May 15, 2014

    Report

    Report Number
    3005099803-2014-01999
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A VISUAL EXAMINATION WAS PERFORMED. THE RETURNED DEVICE HAD A LONGITUDINAL TEAR IN THE BALLOON. THE TEAR STRETCHED FROM THE PROXIMAL MARKERBAND AND IT EXTENDED DISTALLY OVER THE DISTAL MARKERBAND. A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AND MARKERBANDS COULD NOT IDENTIFY ANY ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE TEAR. THIS INVESTIGATION IS THEREFORE ASSIGNED THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF OPERATIONAL CONTEXT. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND REVEALED THAT THERE WERE NO NON-CONFORMING EVENTS OR ANY DEVIATIONS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX BALLOON WAS USED DURING A URETEROSCOPY PROCEDURE ON (B)(6), 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SURGEON USED THE UROMAX BALLOON DILATION CATHETER IN THE RIGHT URETER. THE SURGEON THEN PUSHED IN A SMALL AMOUNT OF FLUID (2-3 MMHG), HE LOOKED AT THE GAUGE ON THE BALLOON, AND IT WAS BARELY REGISTERING. HE THEN STARTED TO TURN THE KNOB ON THE PRESSURE GAUGE AND IT SHOT ALL THE WAY UP TO 26MMHG AND THEN DROPPED DOWN. THE C-ARM SHOWED A WIDE SPREAD OF CONTRAST. VISUALIZATION THROUGH THE SCOPE SHOWED PERITONEAL FAT. THE RIGHT URETER WAS CONFIRMED TO BE RUPTURED. DURING THE PROCEDURE IT WAS NOTED THAT THE PATIENT HAD TWO RIGHT URETERS SO THE SURGEON PLACED A STENT IN BOTH URETERS. THE SURGICAL PROCEDURE WAS ABORTED. PATIENT WAS EXTUBATED AND TAKEN TO THE POST RECOVERY DEPARTMENT. THE CONDITION OF THE PATIENT WAS REPORTED TO BE WELL POST PROCEDURE AND THE PATIENT WAS SENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291914 UROMAX ULTRA? DILATOR, CATHETER, URETERAL EZN BOSTON SCIENTIFIC - GALWAY M0062251090 15052096

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention