BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUATRACK HYDROPHILIC GUIDEWIRE

    MDR report key: 1944220 · Received December 6, 2010

    Report

    Report Number
    1625425-2010-00027
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE DR. WAS TRYING TO PUNCTURE THE ARTERY WITH A NEEDLE (B)(4) AND HE INSERTED THE GUIDEWIRE (B)(4) INSIDE THE NEEDLE. HE FELT THAT THE GUIDE DIDN'T ADVANCE SO HE REMOVED THE GUIDE AND THE NEEDLE IN ORDER TO TRY AND PUNCTURE IN ANOTHER PLACE AS HE DIDN'T REACH THE ARTERY AT FIRST TRY. WHEN HE REMOVED THE GUIDE, HE REALIZED THAT A LITTLE PIECE OF COATING OF THE WIRE WAS LEFT IN THE PATIENT, BUT NOT INTO THE ARTERY, JUST BEFORE THE ARTERY WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUATRACK HYDROPHILIC GUIDEWIRE AQUATRACK GUIDEWIRE DQX ARGON MEDICAL DEVICES, INC. NA 80003034

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR