BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2715545 · Received August 23, 2012

    Report

    Report Number
    2030404-2012-00226
    Event Type
    Injury
    Date Received
    August 23, 2012
    Date of Event
    August 10, 2012
    Report Date
    August 10, 2012
    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

    THE DEVICE WAS NOT AVAILABLE AT SJM; THEREFORE, A PHYSICAL EVALUATION OF THE PRODUCT COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION FOR THE REPORTED PERICARDIAL EFFUSION 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 A LEFT VENTRICULAR OUTFLOW TRACT (LVOT) ABLATION PROCEDURE, USING A THERAPY COOL FLEX ABLATION CATHETER, A PERICARDIAL EFFUSION OCCURRED. A NON-SJM CATHETER WAS PLACED IN THE CORONARY SINUS AND A SJM JSN CATHETER WAS PLACED IN THE RIGHT VENTRICLE. THE PHYSIOLOGIST INSERTED THE COOL FLEX CATHETER USING A RETROGRADE APPROACH; THEREFORE, NO TRANSSEPTAL PUNCTURE WAS PERFORMED. THE PHYSICIAN SUCCESSFULLY PERFORMED THE ABLATION AND WAS WAITING TO CONFIRM THAT NO ELECTRICAL IMPULSES ORIGINATED FROM THE LVOT. DURING THIS WAITING PERIOD, THE PT COMPLAINED OF SLIGHT CHEST PAIN AND BLOOD PRESSURE DROPPED. THE PHYSICIAN PERFORMED AN ECHOCARDIOGRAM AND CONFIRMED A PERICARDIAL EFFUSION IN THE LEFT ATRIUM. A PERICARDIOCENTESIS WAS PREFORMED, THE EFFUSION WAS STOPPED, AND THE PROCEDURE WAS ABORTED. THE PT WAS INSTABLE CONDITION WITH NO FURTHER SURGICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL FLEX, 1304-CF-7-0.5(5)2 CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 88015 3688329

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention IBI ABLATION GENERATOR| COOL POINT IRRIGATION PUMP| BARD CLEARSIGN RECORDING SYSTEM| SJM JSN CATHETER| BARD DYNDECA