BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 4608668 · Received March 12, 2015

    Report

    Report Number
    3004193842-2015-00008
    Event Type
    Injury
    Date Received
    March 12, 2015
    Date of Event
    March 3, 2015
    Report Date
    March 10, 2015
    Manufacturer
    CREGANNA MEDICAL DEVICES
    Product Code
    DYB
    PMA / PMN Number
    K140338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "AT THE END OF THE PROCEDURE THE ECHOGRAPHYST NOTICED A LITTLE PERICARDIAL EFFUSION (3-4MM) FORMED AFTER PROCEDURE. LATER IT BECAME 10MM. PROTAMINE WAS ADMINISTERED AND PHYSICIANS DECIDED TO DON'T PERFORM PERICARDIOCENTESIS SINCE PERICARDIAL EFFUSION DIDN'T INCREASE. AFTER SOME HOURS THE PT WAS STABLE WITHOUT PROBLEMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170094 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL DEVICES NTR18 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention