BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGONFLY

    MDR report key: 3042068 · Received April 3, 2013

    Report

    Report Number
    3004672267-2013-00002
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NQQ
    PMA / PMN Number
    K093857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN OCT IMAGING PROCEDURE, THE PHYSICIAN ADVANCED THE UNSPECIFIED GUIDE WIRE AND DRAGONFLY CATHETER THROUGH A 50% RESTENOSED STENT LOCATED IN THE NON-TORTUOUS INTER-VENTRICULAR ARTERY (VA). THE PHYSICIAN HAD DIFFICULTY PLACING THE DRAGONFLY CATHETER THROUGH THE IMAGING REGION. AFTER THE DRAGONFLY CATHETER WAS POSITIONED, CONTRAST WAS INJECTED. DUE TO POOR BLOOD CLEARING, THE PHYSICIAN HAD DIFFICULTIES VISUALIZING THE RESTENOSED STENT AND SURROUNDING VESSEL TOMOGRAPHY. THE PT EXPERIENCED PAIN AND THE PHYSICIAN NOTED VIA ELECTROCARDIOGRAM AND AN UNSPECIFIED 'BIOLOGICAL TEST' THAT A THROMBUS OCCURRED. THE THROMBUS WAS LOCATED AND REMOVED FROM THE PT. THE PT WAS TRANSFERRED TO INTENSIVE CARE POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135922 DRAGONFLY INTRAVASCULAR IMAGING CATHETER NQQ ST. JUDE MEDICAL 13751-02 DF-12-865

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R