BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOL PATH DUO 7F CATHETER 1302-CP2-7-2-NS-TE4BE1

    MDR report key: 1977588 · Received January 31, 2011

    Report

    Report Number
    2030404-2011-00024
    Event Type
    Death
    Date Received
    January 31, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 6, 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

    THE DEVICE WAS NOT RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER FOR THE DEVICE IS UNK. THE CAUSE FOR THE REPORTED EVENT IS UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE COOL PATH DUO CATHETER WAS USED IN CONJUNCTION WITH THE HANSEN ROBOTIC SYSTEM AND THE ARTISAN CONTROL CATHETER TO PERFORM ATRIAL FIBRILLATION ABLATION ON (B)(6) 2010. THE COOL PATH DUO CATHETER WAS PLACED INSIDE THE ARTISAN CONTROL CATHETER AND THE PHYSICIAN ACCESSED THE LEFT ATRIUM THROUGH THE TRANSSEPTAL PUNCTURE PERFORMED EARLIER IN THE PROCEDURE. THE PHYSICIAN HAD PERFORMED 12 MINUTES OF RF ABLATION AT 25 WATTS WITH A 45 DEGREE TEMPERATURE LIMIT WHEN IT WAS NOTED THE PT'S BLOOD PRESSURE BEGAN TO DECREASE AND ECHOCARDIOGRAPHY REVEALED THAT THE ARTISAN CONTROL CATHETER ALONG WITH THE COOL PATH DUO CATHETER WERE IN THE PERICARDIUM. TRANSCUTANEOUS PUNCTURE WAS PERFORMED AND THE ONLY THING EXTRACTED FROM THE PERICARDIUM WAS THE LIQUID PERFUSED THROUGH THE ARTISAN CONTROL CATHETER. ABLATION WAS CONTINUED CONVENTIONALLY WITH A COOL PATH DUO CATHETER IN THE LEFT ATRIA WITH NO FURTHER PROBLEMS NOTED. ESOPHAGEAL TEMPERATURE WAS MONITORED USING A TEMPERATURE PROBE DURING THE PROCEDURE. THE PT REPORTEDLY RECOVERED NORMALLY AND WAS STABLE AFTER THE PROCEDURE. ON (B)(6) 2010, THE PT WAS READMITTED TO THE HOSPITAL WITH AN AIR EMBOLISM. AN ATRIO-ESOPHAGEAL FISTULA WAS DISCOVERED AND PT SUBSEQUENTLY DIED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUO 7F CATHETER 1302-CP2-7-2-NS-TE4BE1 NONE OAD ST. JUDE MEDICAL, IRVINE 88008 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death HANSEN ROBOTIC| ARTISAN CONTROL CATHETER