BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOL PATH 7F, 1304-CP-7-25-M

    MDR report key: 2234227 · Received August 19, 2011

    Report

    Report Number
    2030404-2011-00243
    Event Type
    Death
    Date Received
    August 19, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ST JUDE MEDICAL, 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

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION 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 THAT DURING A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WHILE ABLATING WITH THE COOL PATH CATHETER, A STEAM POP OCCURRED WHICH RESULTED IN CARDIAC TAMPONADE AND SUBSEQUENT DEATH. THE PT SUFFERED ELECTRICAL STORM 2 DAYS PRIOR TO ABLATION PROCEDURE AND RECEIVED 7 SHOCKS AND 900 ATP (ANTITACHYCARDIA PACING) THERAPIES FROM HER ICD. THE PT WAS REPORTEDLY VERY UNSTABLE BEFORE THE ABLATION PROCEDURE REQUITING INTUBATION. THE ABLATION PROCEDURE WAS CONSIDERED A "LAST CHANCE" TREATMENT. THE PHYSICIAN WAS ABLATING WITH THE THERAPY COOL PATH ABLATION CATHETER IN THE RIGHT VENTRICULAR OUTFLOW TRACT AND COMPLETED TWO 60 SECOND RADIO FREQUENCY (RF) ABLATIONS. VELOCITY MAPPING, PACE MAPPING AND ANOTHER 60 SECOND RF ABLATION WERE PERFORMED WHEN A STEAM POP WAS HEARD AND CARDIAC TAMPONADE WAS CONFIRMED. THE ABLATION PARAMETERS WERE 30W, 40 DEGREES C, 30 ML/ML WITH A NON-SJM GENERATOR. A PERICARDIALCENTISIS WAS PERFORMED, HOWEVER, NO BLOOD COULD BE DRAINED. THE PT REQUIRED CARDIAC SURGERY TO OPEN THE PERICARDIUM AND MANUALLY REMOVE LARGE BLOOD CLOTS. THE PT SUBSEQUENTLY DIED A FEW MINUTES LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH 7F, 1304-CP-7-25-M NONE OAD ST JUDE MEDICAL, IRVINE 83352 3265698

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death