BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCEND AQ URETERAL BALLOON CATHETER

    MDR report key: 3760921 · Received April 9, 2014

    Report

    Report Number
    1820334-2014-00165
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    COOK UROLOGICAL INC
    Product Code
    EZN
    PMA / PMN Number
    K040127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A FEMALE PATIENT UNDERWENT URETEROSCOPY WITH STENT PLACEMENT ON (B)(6) 2014. THE PHYSICIAN PASSED THE BALLOON TO DILATE THE PROXIMAL URETER. THE BALLOON RUPTURED (THE COOK REP BELIEVES THIS MIGHT BE DUE TO OVER INFLATION). THEY COULD NOT GET PAST THE STRICTURE. THERE WAS TRAUMA TO URETER. A STENT WAS PLACED. IT IS UNKNOWN IF THE BALLOON RUPTURE CAUSED THE TRAUMA TO THE URETER OR A NEED FOR INTERVENTION. THE TRAUMA COULD HAVE BEEN CAUSED BY OVERINFLATION. A STENT IS USUALLY PLACED AT END OF THIS TYPE OF PROCEDURE. THE PATIENT MAY REQUIRE AN ADDITIONAL PROCEDURE TO PERFORM A LITHOTRIPSY PROCEDURE THAT TWAS ORIGINALLY INTENDED TO BE PERFORMED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213268 ASCEND AQ URETERAL BALLOON CATHETER EZN DILATOR, CATHETER, URETERAL EZN COOK UROLOGICAL INC NA U2436478

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other