BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGONFLY IMAGING CATHETER

    MDR report key: 2632374 · Received June 25, 2012

    Report

    Report Number
    3004672267-2012-00004
    Event Type
    Injury
    Date Received
    June 25, 2012
    Date of Event
    May 30, 2012
    Report Date
    June 22, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NKK
    PMA / PMN Number
    K093857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND THE DEVICE WAS MANUFACTURING IN ACCORDANCE TO SJM SPECIFICATION. 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

    THE IMAGING VESSEL WAS STENTED AND THEN OCT IMAGING WAS ATTEMPTED FOR STENT ASSESSMENT. DURING CATHETER INSERTION SOME RESISTANCE WAS FELT AND IT DID NOT FEEL LIKE A TYPICAL SMOOTH DELIVERY. PHYSICIAN NOTICED THE CATHETER BUCKLED PROXIMAL TO THE SECOND MARKER BAND WHERE A DISSECTION WAS SEEN. DISSECTION WAS STENTED AND PATIENT IS FINE. PHYSICIAN IS A ROUTINE OCT USER AND THE CAUSE OF THE DISSECTION IS UNCLEAR. THE PHYSICIAN STATED THAT THE EVENT MAY HAVE BEEN CAUSED BY THE CATHETER.

    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-12-026

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention