BEUDAMED
    FDA Adverse Event Summary report: N

    FLEXOR URETERAL ACCESS SHEATH WITH AQ HYDROPHILIC COATING

    MDR report key: 2855597 · Received November 28, 2012

    Report

    Report Number
    MW5027834
    Date Received
    November 28, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 13, 2012
    Manufacturer
    COOK UROLOGICAL INC.
    Product Code
    EYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD CYSTOSCOPY, BILATERAL RETROGRADE PYELOGRAPHY, LEFT URETEROSCOPIC HOLMIUM YAG LASER LITHOTRIPSY, STONE RETRIEVAL, LEFT DOUBLE J STENT EXCHANGE AND RIGHT DOUBLE-J STENT EXCHANGE FOR A 5-FRENCH OPEN-ENDED URETERAL CATHETER. A 14-FRENCH X 35 CM COOK URETERAL SHEATH AND OBTURATOR WAS THEN PASSED OVER THE AMPLATZ WIRE THROUGH THE URETHRA AND INTO THE BLADDER UP THE URETER UNDER FLUOROSCOPIC CONTROL. DURING THE PROCEDURE THE COOK URETERAL ACCESS SHEATH BEGAN FLAKING PLASTIC PARTICLES INTO THE DISTAL URETER INTRA-OP. THESE PARTICLES HAD TO BE RETRIEVED THUS RESULTING IN LENGTHENED TIME UNDER ANESTHESIA. THE SURGEON THEN REPLACED THE COOK URETERAL SHEATH WITH A 14X55 CM SHEATH. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR URETERAL ACCESS SHEATH WITH AQ HYDROPHILIC COATING URETERAL ACCESS SHEATH EYB COOK UROLOGICAL INC. FUS-140035 U2211706

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention