BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGONFLY IMAGING CATHETER

    MDR report key: 2688249 · Received August 7, 2012

    Report

    Report Number
    3004672267-2012-00005
    Event Type
    Injury
    Date Received
    August 7, 2012
    Date of Event
    July 10, 2012
    Report Date
    August 3, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NKK
    PMA / PMN Number
    K098357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND THE DEVICE WAS MANUFACTURED IN ACCORDANCE TO SJM SPECIFICATIONS. A REQUEST HAS BEEN PLACED TO THE HOSPITAL FOR IMAGES AND THE DEVICE AND UPON RECEIPT, FURTHER INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    AN OCT PROCEDURE OF THE LEFT CIRCUMFLEX ARTERY WAS BEING PERFORMED AND THE DRAGONFLY CATHETER WAS NOT ABLE TO CROSS A CIRCUMFLEX LESION. AFTER PULLING THE DRAGONFLY CATHETER BACK INTO THE GUIDE (EBU 3.75), A CINE WAS PERFORMED AND A DISSECTION OF THE LEFT MAIN ARTERY WAS OBSERVED. THE PATIENT WAS ON MEDICATIONS OF 75 MG PLAVIX AND ANGIOMAX DURING THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE CCU AND TREATED WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGONFLY IMAGING CATHETER INTERVASCULAR IMAGING CATHETER NKK ST. JUDE MEDICAL 13751-02 DF-12-545

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention