BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER

    MDR report key: 9779915 · Received March 3, 2020

    Report

    Report Number
    3009600098-2020-00006
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    February 5, 2020
    Report Date
    March 3, 2020
    Manufacturer
    ST. JUDE MEDICAL CATD
    Product Code
    DQO
    UDI-DI
    00183739000654
    PMA / PMN Number
    K141453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THERE WAS NO REFLOW IN THE VESSEL WHICH WAS CHARACTERIZED BY SLOW FLOW OF CONTRAST THROUGH THE ARTERY WHILE THE DEVICE WAS INSIDE THE VESSEL. MEDICATIONS SUCH AS NICARDIPINE, ATROPINE, AND DOPAMINE WERE ADMINISTERED TO RE-ESTABLISH TIMI IIII FLOW IN ORDER TO RESOLVE THE ISSUE. (CRD_907 ILUMIEN IV, US3529-6907).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243524 DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO ST. JUDE MEDICAL CATD C408646 7322455 00183739000654

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention