BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3434196 · Received October 24, 2013

    Report

    Report Number
    2030404-2013-00079
    Event Type
    Injury
    Date Received
    October 24, 2013
    Date of Event
    October 3, 2013
    Report Date
    October 3, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    P110016/S008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED CARDIAC TAMPONADE WAS THE ABLATION ON A VERY THIN AND ISCHEMIC LEFT VENTRICULAR WALL. PER THE IFU, VASCULAR PERFORATION IS AN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 1

    DURING A PVC ABLATION PROCEDURE USING A THERAPY COOL FLEX ABLATION CATHETER, A CARDIAC TAMPONADE OCCURRED. THE PHYSICIAN PERFORMED TRANSSEPTAL PUNCTURE WITH A BRK TRANSSEPTAL NEEDLE AND A SWARTZ INTRODUCER. USING A GUIDEWIRE FOR SUPPORT, AN ENSITE ARRAY MULTI-ELECTRODE CATHETER WAS ADVANCED THROUGH THE FOSSA OVALIS AND PLACED IN THE LEFT VENTRICULAR APEX. THE THERAPY COOL FLEX ABLATION CATHETER WAS ADVANCED VIA A RETROGRADE APPROACH INTO THE LEFT VENTRICLE MAPPING WAS PERFORMED AND THE ORIGINATION OF THE PVCS WAS NOTED TO BE IN THE ANTERIOR PORTION OF THE LEFT VENTRICULAR APEX. TWO WAS COMPLETED; HOWEVER, ONE HOUR LATER THE PATIENT BECAME BRADYCARDIC. A CARDIAC TAMPONADE WAS DIAGNOSED AND A PATCH ON THE APEX OF THE LEFT VENTRICLE. THE PHYSICIAN BELIEVES A CARDIAC PERFORATION MOST LIKELY OCCURRED DURING ABLATION BECAUSE THE PATIENT HAD A VERY THIN AND ISCHEMIC LEFT VENTRICULAR WALL. NO PERFORMANCE ISSUES WERE NOTED WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546239 THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L-TE4BE1EB CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC. (AF-IRVINE) A088016 4159211

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention LIVEWIRE DECAPOLAR EP CATHETER, (B)(4), LOT UNK| BRK TRANSSEPTAL NEEDLE, (B)(4), LOT UNK| ENSITE ARRAY CATHETER, (B)(4)| COOL POINT IRRIGATION PUMP, (B)(4), LOT UNK| SWARTZ INTRODUCER, (B)(4), LOT UNK