BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAGONFLY

    MDR report key: 2581073 · Received May 16, 2012

    Report

    Report Number
    2581073
    Event Type
    Malfunction
    Date Received
    May 16, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 16, 2012
    Manufacturer
    LIGHT LAB IMAGING, DIV ST. JUDE MEDICAL
    Product Code
    NQQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    OCT (OPTICAL COHERENCE TOMOGRAPHY) SYSTEM WOULD NOT RECOGNIZE THE CATHETER. CATHETER WAS CONNECTED TO ITS AUTOMATIC WITHDRAWAL DEVICE AND THE "CLICK" INSURED THAT THERE WAS A GOOD CONNECTION. THE SYSTEM WOULD NOT RECOGNIZE THE CATHETER AND IT KEPT PROMPTING TO CONNECT AND REPEAT THE AUTO CALIBRATE STEP. TRIED A DIFFERENT CATHETER AND IT WORKED FINE. NOT DOCUMENTED IF IT WAS THE SAME LOT # AS THE DEFECTIVE DEVICE. PATIENT OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGONFLY CATHETER, IMAGING, OPTICAL COHERENCE TOMOGRAPHY NQQ LIGHT LAB IMAGING, DIV ST. JUDE MEDICAL * DF-11-857

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR NO OTHER THERAPIES