BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUATRACK HYDROPHILIC GUIDEWIRE

    MDR report key: 1873578 · Received September 16, 2010

    Report

    Report Number
    1625425-2010-00011
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN-PROCESS AND THE RESULTS OF THE INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT WHEN COMPLETED.

    Description of Event or Problem · 1

    PIECE OF WIRE BROKE OFF IN PATIENT. WIRE WAS BEING USED IN A CATHETER TO RETRIEVE A VENA CAVA FILTER. PIECE OF CATHETER AND WIRE BROKE OFF. THE PHYSICIAN INDICATED IN HIS REPORT THAT THE PIECE OF WIRE EMBOLIZED TO THE PULMONARY WITH NO CLINICAL SIGNIFICANCE. CUSTOMER WAS EVALUATING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUATRACK HYDROPHILIC GUIDEWIRE AQUATRACK WIRE DQX ARGON MEDICAL DEVICES INC. NA 80000369

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK