BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQVATRACK

    MDR report key: 1893440 · Received November 5, 2010

    Report

    Report Number
    1893440
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    July 13, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING HEART CATHETERIZATION, END OF WIRE SHEARED OFF WHILE BEING PULLED BACK THROUGH NEEDLE. THIS RESULTED IN FOREIGN BODY LEFT BEHIND IN SUBCUTANEOUS TISSUE OF RIGHT LEG. PHYSICIAN STATES PROCEDURE WAS ABORTED SECONDARY TO BILATERAL ILIAC DISEASE AND UNABLE TO PASS THROUGH / ADVANCE PROXIMATELY. PHYSICIAN STATES HE FEELS THAT THE RISKS OF ANY SURGICAL INTERVENTION IS GREATER FOR THE PT THAN LEAVING THE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQVATRACK NONE DQX ARGON MEDICAL DEVICES C3518-RSA 80000683

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR