BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMPLATZER

    MDR report key: 609654 · Received May 17, 2005

    Report

    Report Number
    609654
    Event Type
    Other
    Date Received
    May 17, 2005
    Date of Event
    May 10, 2005
    Report Date
    May 17, 2005
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ELECTIVELY SCHEDULED FOR ATRIAL SEPTAL DEFECT DEVICE CLOSURE IN THE CARDIAC CATH LAB. A SIZING BALLOON WAS AVAILABLE. FACILITY BELIEVES THAT THE PHYSICIAN FELT COMFORTABLE USING THE INFORMATION PROVIDED BY THE ECHOCARDIOGRAM, RATHER THAN THE SIZING BALLOON. A SIZE 12 DEVICE WAS INSERTED BUT FOUND TO BE TOO SMALL. A SIZE 14 WAS THEN INSERTED BUT WAS ALSO TOO SMALL. AS A SIZE 16 WAS BEING INSERTED, IT POPPED THROUGH AND ENTERED THE AORTA. A SNARE WAS INSERTED TO RETRIEVE THE DEVICE AND APPROXIMATELY ONE HOUR LATER, THE DEVICE WAS RETRIEVED. THE PATIENT EXPERIENCED WHAT WAS DESCRIBED AS A VASO-VAGAL REACTION AND REQUIRED ATROPINE. THE PATIENT'S BLOOD PRESSURE DROPPED INTO THE 80'S AND THEIR PULSE INCREASED. THE CAMERA WAS USED TO TAKE PICTURES OF THE AORTA TO LOOK FOR DAMAGE OR RUPTURE, AND NONE WERE FOUND. THE MANUFACTURER WAS CONTACTED FOLLOWING THE EVENT. IT IS UNKNOWN AT THIS TIME IF THE DEVICE HAS BEEN PICKED UP BY THE MANUFACTURER'S REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER CARDIAC DEFECT CLOSURE DEVICE - SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION * M02I10-02

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR