BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL PATH CATHETER 7F, 1304-CP-7-25-M-AB

    MDR report key: 2903492 · Received January 3, 2013

    Report

    Report Number
    2030404-2012-00311
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED FOR ANALYSIS. WHEN OUR INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CARDIAC TAMPONADE OCCURRED DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE. AFTER ABLATING THE LEFT SUPERIOR PULMONARY VEIN, THE LEFT INFERIOR PULMONARY VEIN, AND THE MITRAL LINE WITH A COOL PATH ABLATION CATHETER, THE PHYSICIAN NOTED A DECREASE IN CARDIAC MOVEMENT VIA FLUOROSCOPY. AN ECHOCARDIOGRAM REVEALED A CARDIAC TAMPONADE, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED. THE PT WAS STABLE AND CONSCIOUS AFTER THE PROCEDURE. THE PHYSICIAN BELIEVES THE CARDIAC PERFORATION OCCURRED DURING THE ABLATION OF THE POSTERIOR WALL OF THE HEART. THERE WERE NO PERFORMANCE ISSUES NOTED DURING THE USE OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3397 COOL PATH CATHETER 7F, 1304-CP-7-25-M-AB CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC. (AF-IRVINE) 83503 3578303

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention