BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY? COOL FLEX? ABLATION CATHETER IRRIGATED 4 MM TIP THERMOCOUPLE QUADRIPOLA

    MDR report key: 4821470 · Received June 5, 2015

    Report

    Report Number
    2030404-2015-00048
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    May 28, 2015
    Report Date
    May 28, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    OAD
    PMA / PMN Number
    P110016/S009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PERICARDIAL EFFUSION MAY HAVE BEEN PROCEDURE RELATED. PER THE IFU, VASCULAR PERFORATION IS AN INHERENT RISK DURING ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 1

    DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. VIA A RETROGRADE APPROACH, THE LEFT VENTRICLE WAS MAPPED, INDICATING THE EARLIEST ACTIVATION POINT WAS IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). DURING ABLATION OF THE LVOT USING A THERAPY COOL FLEX ABLATION CATHETER, THE PATIENT COMPLAINED OF CHEST PAIN AND BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE. PROTAMINE WAS ADMINISTERED AND A PERICARDIOCENTESIS WAS PERFORMED, WHICH STABILIZED THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE CSU WITH A PERICARDIAL DRAIN IN PLACE FOR MONITORING. THE DRAIN WAS REMOVED THE NEXT MORNING AND A FOLLOW UP ECHOCARDIOGRAM REVEALED NO FURTHER EVIDENCE OF EFFUSION. THE PATIENT WAS THEN DISCHARGED IN GOOD CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364341 THERAPY? COOL FLEX? ABLATION CATHETER IRRIGATED 4 MM TIP THERMOCOUPLE QUADRIPOLA CATHETER, PERCUTANEOUS CARDIAC ABLATION OAD ST. JUDE MEDICAL, INC. A088016 4843815

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention