BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUATRACK HYDROPHILIC GUIDEWIRE

    MDR report key: 1900430 · Received October 27, 2010

    Report

    Report Number
    1625425-2010-00015
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PART NUMBER OR LOT NUMBER PROVIDED WITH COMPLAINT. PER THE INSTRUCTIONS FOR USE THAT IS DISTRIBUTED WITH THIS PRODUCT, THE FOLLOWING PRECAUTION IS STATED: "DO NOT USE A METAL TORQUE DEVICE OR METAL INSERTION TOOL ON A HYDROPHILIC GUIDEWIRE. THIS MAY DAMAGE AND/OR COMPROMISE THE INTEGRITY OF THE COATING." NO LOT NUMBER PROVIDED WITH COMPLAINT; THEREFORE, UNABLE TO REVIEW DEVICE HISTORY RECORD. THE FAILURE COULD NOT BE VERIFIED DUE TO NO SAMPLE BEING RETURNED; THEREFORE, NO ROOT CAUSE COULD BE DETERMINED. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE AQUATRACK WAS BEING USED FOR INITIAL ARTERIAL ACCESS WITH A (NON-CORDIS) NEEDLE, WHICH CAME APART AT THE HUB. DURING THIS PROCESS, PART OF THE WIRE'S HYDROPHILIC COATING SHAVED OFF AND REMAINED IN THE TISSUE TRACT-NOT IN THE VASCULATURE. THE PIECE WAS VISIBLE ON X-RAY AND APPEARED TO BE >/=5CM LONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUATRACK HYDROPHILIC GUIDEWIRE AQUATRACK WIRE DQX ARGON MEDICAL DEVICES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK