BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL PATH DUO 7F, 1304-CP2-7-1.5(5)2-M-TE4BE1AB

    MDR report key: 2000952 · Received February 18, 2011

    Report

    Report Number
    2030404-2011-00049
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CARDIAC TAMPONADE IS AN INHERENT RISK ASSOCIATED WITH ANY CARDIAC ABLATION PROCEDURE. THE CAUSE FOR THIS REPORTED EVENT IS UNKNOWN. THE FOLLOWING DATES ARE ESTIMATED.

    Description of Event or Problem · 1

    IT WAS REPORTED AT THE END OF AN ATRIAL FIBRILLATION ABLATION PROCEDURE, AFTER ISOLATING THE LEFT PULMONARY VEINS AND THE MITRAL ISTHMUS LINE, A CARDIAC TAMPONADE WAS DETECTED ON XRAY. BLOOD PRESSURE AND OXYGEN SATURATION LEVELS REMAINED STABLE AND A PERICARDIOCENTESIS WAS PERFORMED TO RESOLVE THE TAMPONADE. THE CAUSE FOR THE TAMPONADE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUO 7F, 1304-CP2-7-1.5(5)2-M-TE4BE1AB NONE OAD ST. JUDE MEDICAL, IRVINE 83562 3262214

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SL| INQUIRY OPTIMA MODEL # 614073