BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONE TIP WITH OPEN END

    MDR report key: 1062407 · Received June 9, 2008

    Report

    Report Number
    1062407
    Event Type
    Malfunction
    Date Received
    June 9, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 9, 2008
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A NUMBER 5 FRENCH CONE TIPPED CATHETER WAS INSERTED INTO THE RIGHT URETERAL ORIFICE WITHOUT ANY DIFFICULTY NEXT TO THE RIGHT URETERAL CATHETER. THE OPEN END OF THE URETERAL CATHETER WAS REMOVED LEAVING THE CONE TIP CATHETER IN PLACE. AN ATTEMPT WAS MADE TO ADVANCE A GUIDEWIRE THROUGH THE CONE TIP CATHETER UP THE URETER, BUT DUE TO THE TORTUOSITY, THE WIRE WOULD NOT ADVANCE READILY. THE CONE TIP CATHETER WAS ADVANCED TO THE LEVEL OF THE UPJ (URETEROPELVIC JUNCTION), AND THE GUIDEWIRE WAS THEN ABLE TO BE ADVANCED TO THE RIGHT RENAL PELVIS WITHOUT DIFFICULTY. THE CONE TIP CATHETER WAS REMOVED. A NUMBER 6, 26 DOUBLE-J URETERAL STENT WAS THEN ADVANCED OVER THE GUIDEWIRE INTO THE RIGHT URETER WITHOUT DIFFICULTY. UPON ADVANCEMENT OF THE DOUBLE-J STENT UNDER FLUOROSCOPY, IT APPEARED THAT THE TIP OF THE CONE TIP CATHETER HAD BROKEN OFF AS IT WAS BEING REMOVED. THE STENT WAS ADVANCED INTO THE RENAL PELVIS AND THE TIP REMAINED THERE. THE TIP WAS LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONE TIP WITH OPEN END CATHETER, URETERAL FAD COOK UROLOGICAL, INC. G14717 U1699321

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR NO OTHER THERAPIES| NO OTHER THERAPIES