BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACLUDE

    MDR report key: 3852079 · Received June 5, 2014

    Report

    Report Number
    3008500478-2014-00084
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXC
    PMA / PMN Number
    K113182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION CURRENTLY UNDERWAY INTO ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    ON MAY 20TH, 2014 WE WERE MADE AWARE OF A CONCERN THAT DURING A ROBOTIC MITRAL VALVE REPAIR AN INTRACLUDE AORTIC OCCLUSION DEVICE WAS USED AND THE BALLOON WAS PLACED UNDER TEE GUIDANCE AND VISUALIZED IN THE AORTA AT THE STJ PRIOR TO INFLATION. THE VENT WAS TURNED ON AT TIME OF ARREST. THE ROOT PRESSURE IMMEDIATELY WENT TO ZERO WITHOUT ANY VOLUME IN THE BALLOON. THE VENT WAS TURNED OFF AND THE PROCESS WAS REPEATED WITH THE SAME RESULT. THE DEVICE WAS REMOVED AND ANOTHER BALLOON WAS PLACED FOR THE CASE. EVALUATION: MANUFACTURING RECORDS WERE REVIEWED AND THERE WERE NO RELATED MANUFACTURING NON-CONFORMANCES IDENTIFIED. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND NO KINKS OR DEFORMITIES. TESTING OF THE DEVICE FOUND THAT AIR WOULD NOT FLOW THROUGH THE ROOT PRESSURE LUMEN. THE TIP OF THE LUMEN WAS FOUND TO BE OCCLUDED. THE OCCLUSION IN THE ROOT VENT LINE WAS PUSHED OUT WITH A PIN. THE OCCLUSION WAS CONSISTENT WITH DRIED BLOOD. THE SOURCE WHICH INITIATED THE OCCLUSION WAS UNABLE TO BE DEFINITIVELY DETERMINED BUT APPEARED TO BE PHYSIOLOGICAL IN NATURE. THE APPEARANCE WAS WHITISH YELLOW AND SIMILAR TO THAT OF A THROMBUS OR CALCIUM. THE CLINICAL OBSERVATION WAS CONFIRMED. BASED ON THE AVAILABLE INFORMATION THE OCCLUSION APPEARED TO BE SECONDARY TO DRIED BLOOD WHICH WAS INITIATED THROMBUS OR CALCIUM. THE INSTRUCTIONS FOR USE, TRAINING, AND RISK CONTROL MEASURES ARE APPROPRIATE AT THIS TIME. NO CAPA IS APPLICABLE AS NO MANUFACTURING DEFECT WAS CONFIRMED. TRENDS FOR THIS COMPLAINT ARE IN CONTROL AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF AN INTRACLUDE AORTIC DEVICE, ICF100, "THEY PLACED THE BALLOON IN THE USUAL FASHION UNDER TEE GUIDANCE AND VISUALIZED IT IN THE AORTA AT THE STJ PRIOR TO INFLATION. WHEN THEY WENT TO ARREST THEY TURNED ON THE VENT AS PER STANDARD PROTOCOL. THE ROOT PRESSURE IMMEDIATELY WENT TO ZERO WITHOUT ANY VOLUME IN THE BALLOON. THEY TURNED THE VENT OFF AND REPEATED WITH THE SAME RESULT. [THE PHYSICIAN] MOVED THE BALLOON BACK JUST A SMALL AMOUNT THINKING IT MAY BE AGAINST THE WALL AND HAD THE SAME PROBLEM. AT THAT POINT THEY PREPPED ANOTHER BALLOON AND SWITCHED IT OUT ON THE FIELD SO THEY COULD PROCEED WITH THE CASE. " THIS CASE WAS A ROBOTIC MVR THE OR TIME WAS PROLONGED BY ABOUT 5-7 MINUTES WHILE THEY SWITCHED OUT THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329764 INTRACLUDE CLAMP, VASCULAR DXC EDWARDS LIFESCIENCES ICF100 59718187

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR