BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUATRACK HYDROPHILIC GUIDEWIRE

    MDR report key: 1944221 · Received December 6, 2010

    Report

    Report Number
    1625425-2010-00028
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER INDICATED THAT DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    AQUATRACK WAS ENTERED THROUGH A STAINLESS STEEL NEEDLE AND UPON ENCOUNTERING TORTUOSITY WAS ADVANCED AND RETRACTED THROUGH THE NEEDLE. THE WIRE WAS THEN WITHDRAWN FROM PATIENT WITH SIGNIFICANT DAMAGE TO THE POLYMER COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUATRACK HYDROPHILIC GUIDEWIRE AQUATRACK GUIDEWIRE DQX ARGON MEDICAL DEVICES, INC. NA 80003172

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK