BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUCISE RP35 SYSTEM

    MDR report key: 838190 · Received March 7, 2007

    Report

    Report Number
    838190
    Event Type
    Injury
    Date Received
    March 7, 2007
    Date of Event
    February 27, 2007
    Report Date
    March 7, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 22 FR RIGID CYSTOSCOPE WAS PASSED INTO THE URETHRA AND BLADDER UNDER DIRECT VISION. THE RIGHT URETERAL ORIFICE WAS CANNULATED WITH OPEN ENDED CATHETER AND RETROGRADE PYELOGRAM SHOWED A VERY TIGHT DISTAL URETERAL STRICTURE. A 0.038 GLIDEWIRE WAS ABLE TO BE MANIPULATED BEYOND THE STRICTURE. THE OPEN ENDED CATHETER AND WIRE WERE REPLACED BY A 0.038 GUIDEWIRE. THE ACUCISE BALLOON WAS THEN PLACED. WHEN THE BALLOON WAS IN THE URETERAL ORIFICE, THE WIRE WAS PLACED ANTERIORLY AND MEDIALLY. IT WAS DIFFICULT TO MANIPULATE. WHEN THE BALLOON WAS INFLATED, IT APPEARED TO INFLATE EASILY AND WAS FELT INFLATED. WITH INFLATION OF THE BALLOON, THERE WAS GROSS BLOOD COMING FROM THE URETERAL ORIFICE. AS A RESULT, THE PATIENT HAD AN EXPLORATORY LAPAROTOMY, REPAIR OF URETERAL LACERATION, REIMPLANTATION OF THE RIGHT URETER, AND RIGHT STENT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUCISE RP35 SYSTEM CATHETER, SYSTEM, ENDOPYELOTOMY KOD APPLIED MEDICAL RESOURCES CORP. BK 023 *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R NO OTHER THERAPIES