BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTA

    MDR report key: 2521590 · Received March 21, 2012

    Report

    Report Number
    2521590
    Event Type
    Injury
    Date Received
    March 21, 2012
    Date of Event
    March 13, 2012
    Report Date
    March 21, 2012
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US

    Narratives

    Description of Event or Problem · 1

    "MS X WAS A RIGHT AND LEFT HEART CATH. THE PROCEDURE WAS DONE VIA RIGHT INTERNAL JUGULAR AND RIGHT RADIAL ARTERY. THE PATIENT WAS STABLE. ROUTINE PROCEDURE DONE. AFTER FINISHING THE ROUTINE CASE IT WAS DECIDED TO DO A PRESSURE WIRE STUDY TO RULE OUT THE NEED FOR STENTING. NEW TUBING AND TRANSDUCER FOR RIGHT HEART WAS USED. MR Z FLUSHED WITH GOOD COLUMN OF FLUID TO PRIME THE SYSTEM. DR X HAD THE GUIDE AND MR Z SAW DR X PULL BACK WITH SOLID BLOOD FLOW INTO THE SYRINGE. MR Z FLUSHED. THEY PROCEEDED WITH THE CASE AND WHEN THE GUIDE WAS PRIMED WITH CONTRAST, THE PATIENT'S HEART RATE AND BP DROPPED. CODE BLUE (MEDICAL EMERGENCY) WITH CPR STARTED. IAMB INSERTED. ECHO DONE. TRANSFERRED TO CCU".MEDRAD SERVICE PERSON "...DOWNLOADED THE SYSTEM'S "FLIGHT RECORDER" AND FOUND NO ERROR MESSAGES LOGGED. PERFORMED THE AVANTA POST SERVICE INTERVENTIONAL SYSTEM CHECKOUT PER MEDRAD'S PROCEDURE. SYSTEM CHECKED IN GOOD WORKING ORDER AT THIS TIME. UPGRADED TO SOFTWARE 002.013_SH AS PART OF ROUTINE SERVICE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA INJECTOR, CONTRAST DXT MEDRAD, INC. AVANTA *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| O| R