BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COPILOT

    MDR report key: 2223752 · Received August 12, 2011

    Report

    Report Number
    2223752
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ABBOTT
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IN CARDIAC CATH LAB FOR BILATERAL SELECTIVE CORONARY ANGIOGRAM, LEFT HEART CATHETERIZATION AND A CORONARY IVUS. A "COPILOT " MALFUNCTIONED DURING THE PROCEDURE. IT WAS LEAKING FLUID AT DISTAL END. THIS COPILOT WAS REMOVED AND REPLACED WITH ANOTHER ONE. PROCEDURE PROCEDED WITHOUT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COPILOT BLEEDBACK CONTROL VALVE DTL ABBOTT 201 1040791

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR