BEUDAMED
    FDA Adverse Event Summary report: N

    COPILOT

    MDR report key: 2223754 · Received August 12, 2011

    Report

    Report Number
    2223754
    Date Received
    August 12, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ABBOTT
    Product Code
    DTL
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE END OF INTERVENTION ON ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI), AIR WAS INADVERTANTLY INJECTED INTO CORONARY TREE. THE COPILOT AND MANIFOLD WERE USED, EMBOLIZED DISTALLY DOWN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) INTO THE SECOND DIAGONAL. AFTER AN EMBOLUS WAS NOTED, THERE WAS NO CHANGE IN HEART RATE OR BP NOTED. PLANNED INTRA AORTIC BALLOON PUMP (IABP) WAS INSERTED DUE TO STUNNED MYOCARDIUM, NOT DUE TO EMBOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COPILOT BLEEDBACK CONTROL VALVE DTL ABBOTT * *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR CARDIAC DRUGS