BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE HYDROPHILLIC GUIDEWIRE

    MDR report key: 4890794 · Received July 1, 2015

    Report

    Report Number
    2126666-2015-00037
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Report Date
    July 1, 2015
    Manufacturer
    LAKE REGION MFG., INC.
    Product Code
    DQX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT CAN BE PERFORMED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CANNOT BE REVIEWED. IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADDRESS THE STATEMENT, "THERE WERE TWO OR THREE PATIENTS WHO EXPERIENCED THAT THE ZIPWIRE GUIDEWIRE BROKE OFF, WHILE THE DEVICES WERE INSIDE THEM." EVENT DESCRIPTION: "OVER THE LAST YEAR HE HAS HAD 3 STIFF ZIP WIRES BECOME STUCK WHILE ADVANCING THROUGH THE SCOPE. WHEN HE MOVED THE WIRE FORWARD AND BACKWARD TRYING TO GET IT TO MOVE HE WOULD SEE BLACK PIECES OF THE WIRE BREAKING OFF IN THE URETER, AND HAD TO GO BACK IN WITH A GRASPER TO REMOVE THE PIECES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429476 ZIPWIRE HYDROPHILLIC GUIDEWIRE UROLOGICAL CATHETER AND ACCESSOREIS DQX LAKE REGION MFG., INC. M006630205B1

    Patients

    Seq Age Sex Outcome Treatment
    1