BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2113550 · Received June 1, 2011

    Report

    Report Number
    2030404-2011-00158
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE UNABLE TO EVALUATE THE PRODUCT INVOLVED IN THIS INCIDENT SINCE NO COMPONENTS OF THE DEVICE WERE RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    IT WAS REPORTED AT THE END OF A FOUR HOUR ATRIAL FIBRILLATION PROCEDURE, A CARDIAC TAMPONADE WAS DETECTED. AFTER ISOLATING THE RIGHT AND LEFT PULMONARY VEINS AND ABLATING THE ROOF AND THE ANTERIOR LINE, CHANGES WERE NOTED ON X-RAY AND THE PT'S BLOOD PRESSURE AND OXYGEN SATURATIONS DECREASED. THE PHYSICIAN SAID THAT DURING THE LAST ABLATION (ANTERIOR LINE), WITH THE COOLPATH CATHETER, THERE WAS A "POP" AND THE CARDIAC TAMPONADE WAS DETECTED. A PERICARDIOCENTESIS WAS PERFORMED, WHICH RESOLVED THE CARDIAC TAMPONADE. NO FURTHER INTERVENTION FOR THE PT WAS NECESSARY. ADD'L INFO WAS REQUESTED AND IS NOT AVAILABLE AT THIS TIME.

    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 CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 83562 3295866

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention