BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGONFLY DUO IMAGING CATHETER KIT

    MDR report key: 4546353 · Received February 25, 2015

    Report

    Report Number
    3004672267-2015-00001
    Event Type
    Injury
    Date Received
    February 25, 2015
    Date of Event
    February 5, 2015
    Report Date
    February 5, 2015
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    ORD
    PMA / PMN Number
    K093857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DRAGONFLY DUO CATHETER WAS RETURNED TO SJM FOR ANALYSIS. VISUAL INSPECTION IDENTIFIED THE CATHETER HAD A PRESENCE OF DRIED CONTRAST. NO OTHER EXTERNAL VISUAL OR DIMENSIONAL ANOMALIES WERE NOTED. OPTICAL FIBER TESTING WAS PERFORMED AND PASSED INDICATING THE FIBER WAS FOUND TO BE INTACT. A LIQUID PURGE TEST WAS CONDUCTED AND FAILED DUE TO HEAVY PRESENCE OF DRIED CONTRAST SOLUTION. THE CATHETER WAS PLACED IN WARM WATER TO REMOVE THE RESIDUAL DRIED CONTRAST AND THE DEVICE WAS THEN ABLE TO BE FLUSHED. EVALUATION OF THE PURGE PORT WAS CONDUCTED AND IT WAS IDENTIFIED TO HAVE A CLEAN, UNOBSTRUCTED PATHWAY AFTER SOAKING. THE CATHETER LUMEN WAS MICROSCOPICALLY INSPECTED AND NO ANOMALIES WERE NOTED. THE CATHETER LUMEN WAS FOUND TO BE INTACT AND WITHOUT ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. IF ADEQUATE CLEARING IS NOT OBTAINED THE OCT IMAGING SYSTEM WILL NOT INITIATE AN AUTOMATIC PULLBACK. THE CAUSE OF THE REPORTED CLEARING DIFFICULTY IS UNKNOWN.

    Description of Event or Problem · 1

    THE DRAGONFLY DUO CATHETER WAS PLACED IN THE LAD VESSEL. THE CATHETER WAS FLUSHED WITH CONTRAST BUT NO CONTRAST COULD BE SEEN IN LIVE VIEW. THE GUIDING CATHETER WAS NOT INITIALLY PLACED WELL IN THE OSTIUM; THEREFORE, IT WAS PLACED DEEPER AND ANOTHER PULLBACK WAS INITIALIZED BUT THE CONTRAST COULD NOT BE SEEN AGAIN ON LIVE VIEW. AFTER ABOUT 2-3 SECONDS THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION. THE PATIENT BECAME INSTABLE AND A DEFIBRILLATOR WAS USED. THE PROCEDURE WAS ABORTED AFTER THE PATIENT WAS STABLE FOR 10 MINUTES. AFTER FIVE HOURS OF BEING MONITORED IN THE HOSPITAL THE PATIENT WAS STILL STABLE AND HAD NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131955 DRAGONFLY DUO IMAGING CATHETER KIT INTRAVASCULAR IMAGING CATHETER ORD ST. JUDE MEDICAL C408643 4606723

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention