BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT HYDROPHILIC COATED GUIDE WIRE

    MDR report key: 1900585 · Received October 29, 2010

    Report

    Report Number
    1721504-2010-00355
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 5, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQX
    PMA / PMN Number
    K000011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD OR COMPLAINT DATA BASE COULD NOT BE DONE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE. EVALUATION METHOD: OTHER: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATA BASE WAS REVIEWED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT APPROXIMATELY ONE INCH OF THE COATING CAME OFF THE DISTAL TIP OF THE WIRE. THE WIRE WAS BEING USED THROUGH A BALLOON CATHETER WHEN THE WIRE GOT STUCK INSIDE THE CATHETER. THE LAB TECHNICIAN FELT THE WIRE MAY NOT HAVE BEEN PROPERLY HYDRATED. THE COATING FROM THE TIP BROKE OFF INSIDE THE CATHETER DURING THE FISTULOGRAM PROCEDURE. THE CATHETER AND WIRE WERE REMOVED TOGETHER WITHOUT INCIDENT. THERE WAS NO HARM OR INJURY TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT HYDROPHILIC COATED GUIDE WIRE WIRE, GUIDE, CATHETER DQX MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1