BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROPASS URETERAL ACCESS SHEATH

    MDR report key: 4297232 · Received November 26, 2014

    Report

    Report Number
    MW5039368
    Event Type
    Malfunction
    Date Received
    November 26, 2014
    Date of Event
    November 25, 2014
    Report Date
    November 26, 2014
    Manufacturer
    GYRUS ACMI MEDICAL INC.
    Product Code
    KNY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A GUIDE WIRE WAS PASSED UNDER FLUOROSCOPIC GUIDANCE; HOWEVER, THE WIRE WOULD NOT PASS THE PROXIMAL AREA OF STRICTURE. AN ACCESS SHEATH WAS PASSED OVER THE GUIDE WIRE TO ACCESS THE URETER FOR FLEXIBLE URETEROSCOPY. THE PLASTIC TIP OF THE ACCESS SHEATH BROKE INTO SEVERAL PIECES WITHIN THE BLADDER, ON INSERTION. THE ACCESS SHEATH NEVER ENTERED THE URETER. THE ACCESS SHEATH WAS REMOVED AND CYSTOSCOPY WAS PERFORMED TO REMOVE THE PLASTIC TIP PIECES FROM THE BLADDER. ANOTHER ACCESS SHEATH WAS OPENED, AND IT WAS NOTED THAT THE WHITE TIP OF THE 1ST ACCESS SHEATH, WHICH BROKE IN THE BLADDER, WAS VERY BRITTLE, WHILE THE SECOND ACCESS SHEATH WAS VERY PLIABLE. WILL RETURN TO MANUFACTURER IN A FEW DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766912 UROPASS URETERAL ACCESS SHEATH URETERAL ACCESS SHEATH KNY GYRUS ACMI MEDICAL INC. 61224 09A1100334

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR