BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L1-TE4BE1BE

    MDR report key: 2871661 · Received December 11, 2012

    Report

    Report Number
    2030404-2012-00305
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: 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 RECORD CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE CAUSE FOR THE REPORTED EVENT REMAINS UNKNOWN; HOWEVER, THE MOST LIKELY ROOT CAUSE CLASSIFICATION OF THE CARDIAC TAMPONADE 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 DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A CARDIAC TAMPONADE OCCURRED. THE PHYSICIAN USED VELOCITY TO MAP GEOMETRY AND COMPLETED RF ABLATION ON THE LEFT SUPERIOR PULMONARY VEIN WITH A COOL FLEX CATHETER WHEN THERE WAS A COMPLETE POWER OUTAGE IN THE PROCEDURE ROOM. THERE WAS NO X-RAY, EP WORKSTATION, VELOCITY AND NO LIGHTS FOR APPROXIMATELY 10 MINUTES. WHEN THE POWER RETURNED, ALL DEVICES WERE TURNED BACK ON AND THE VELOCITY STUDY WAS RESUMED; GEOMETRY AND THE FIRST POINTS OF RF ABLATION HAD REMAINED ON SCREEN. THERE WERE NO PROBLEMS WITH CATHETERS ON THE MAP AND RF ABLATION WITH THE COOL FLEX WAS REINITIATED. AFTER A FEW MINUTES THE PATIENT EXPERIENCED NAUSEA AND A LOW HEART RATE WHICH REQUIRED INTERNAL PACING TO INCREASE. THE BLOOD PRESSURE THEN DECREASED AND A TRANSTHORACIC ECHOCARDIOGRAM CONFIRMED CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND THE ANTICOAGULATION WAS REVERSED. THE PROCEDURE WAS TERMINATED. THE CURRENT STATUS OF THE PATIENT IS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L1-TE4BE1BE CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC. (AF-IRVINE) 88018 3790380

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention ENSITE VELOCITY