BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC ARCTIC FRONT CRYO BALLOON SYSTEM

    MDR report key: 2012270 · Received February 28, 2011

    Report

    Report Number
    2012270
    Event Type
    Death
    Date Received
    February 28, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 25, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH ATRIAL FIBRILLATION, HAVING EP/CATHETER ABLATION PROCEDURE USING THE MEDTRONIC ARCTIC FRONT CRYO BALLOON SYSTEM AND THE ST JUDE MEDICAL ESI NAVX THREE-DIMENSIONAL MAPPING SYSTEM. THE PROCEDURE WAS COMPLICATED BY A MASSIVE AMOUNT OF AIR INFUSION INTO THE LEFT SIDE OF THE HEART, SUBSEQUENTLY INTO THE AORTA AND DISSEMINATED. THIS RESULTED IN DEATH. THE BALLOON CATHETER WAS WITHDRAWN BACK INTO THE SHEATH IN ANTICIPATION OF REDIRECTING INTO THE RIGHT INFERIOR PULMONARY VEIN. PROCEDURE WAS ONGOING WITHOUT COMPLICATIONS UP TO THIS POINT, HOWEVER, AT THIS STAGE, THE PT HAD A SUDDEN DROP IN BLOOD PRESSURE, FOLLOWED BY BRADYCARDIA. AN EXTREMELY LARGE VOLUME OF OPACIFICATION IN THE LEFT VENTRICLE AND IN THE AORTA WAS NOTED BY FLUOROSCOPY. THEN AIR IN THE AORTA WAS VERIFIED BY CINE. THE BALLOON AT THIS STAGE WAS STILL WITHIN THE SHEATH. EP TECHS NOTED THAT THERE WAS NO AIR NOTED IN THE MANIFOLD OR IN THE MANIFOLD LINES. THE HIGH PRESSURE LINE LEADING TO THE SHEATH WAS NOTED TO HAVE AIR, THE 500 CC SALINE BAG WAS EMPTY AND THERE WAS NO OTHER OBVIOUS SOURCE FOR AIR IDENTIFIED BY THE STAFF. THE SHEATH SYSTEMS WERE THEN QUICKLY WITHDRAWN INTO THE RIGHT SIDE OF THE HEART. THE 10 FRENCH SHEATH WITH THE 8 MM CRYOCATHETER HAD NO OBVIOUS AIR AND THE HEPARINIZED SALINE LINE HAD BEEN GOING AT 75 CC/H AND WAS STILL NOTED TO HAVE SALINE WITH NO BACK-BLEEDING NOTED AND NO AIR IN THIS LINE. THIS INFO WAS GATHERED FROM PROCEDURE REPORT AND HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ARCTIC FRONT CRYO BALLOON SYSTEM CRYO ABLATION CATHETER OAE MEDTRONIC CRYOCATH LP 2AF282 07293

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death