BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L-TE4BE1EB

    MDR report key: 3111282 · Received May 8, 2013

    Report

    Report Number
    2030404-2013-00038
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE THERAPY COOL FLEX CATHETER AS RETURNED FOR EVALUATION. THE CATHETER MET STEERING FORCE AND CURVE SPECIFICATIONS. THE CATHETER PASSED EKG NOISE LEVEL, PRESSURE DROP, ABLATION SIMULATION, ELECTRICAL CONTINUITY, AND FLOW RATE TESTING. THE DEVICE MET SPECIFICATIONS PRIOR TO RELEASE FROM SJM MANUFACTURING FACILITIES AS SUPPORTED BY THE DEVICE HISTORY RECORD. THE CAUSE OF THE PERICARDIAL EFFUSION IS UNKNOWN AS THE EVENT COULD NOT BE CONFIRMED. PER THE IFU, VASCULAR PERFORATION OR DISSECTION IS AN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 1

    DURING A VENTRICULAR OUTFLOW TRACT ABLATION PROCEDURE USING A THERAPY COOL FLEX ABLATION CATHETER, A PERICARDIAL EFFUSION OCCURRED. AFTER THE SECOND APPLICATION OF RF ENERGY, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION; HOWEVER, NO INTERVENTION WAS ADMINISTERED DUE TO THE SMALL SIZE OF THE EFFUSION. THE PATIENT REMAINED STABLE THROUGHOUT AND WAS UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202185 THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L-TE4BE1EB CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC. (AF-IRVINE) A088016 3966236

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR