BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 4023647 · Received August 1, 2014

    Report

    Report Number
    2030404-2014-00080
    Event Type
    Death
    Date Received
    August 1, 2014
    Date of Event
    May 14, 2014
    Report Date
    July 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING AN ATRIAL FIBRILLATION ABLATION PROCEDURE USING A THERAPY COOL PATH DUO ABLATION CATHETER, AN ATRIOESOPHAGEAL FISTULA OCCURRED AND THE PATIENT SUBSEQUENTLY EXPIRED. THE PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE ON (B)(4) 2014. A PULMONARY VEIN ISOLATION PLUS ROOFLINE ABLATION WAS SUCCESSFULLY PERFORMED AND THE PROCEDURE WAS UNEVENTFUL. AT A LATER DATE, AN ATRIOESOPHAGEAL FISTULA WAS DIAGNOSED AND AN ESOPHAGEAL STENT WAS PLACED. THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451693 COOL PATH DUO 7F CATHETER 1302-CP2-7-2-NS-TE4BE1 CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC. (AF-IRVINE) 88008

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death LIVEWIRE DECAPOLAR EP CATHETER| REFLEXION SPIRAL EP CATHETER: D402865, LOT UNK| ENSITE NAVX SYSTEM| HANSEN ROBOTIC SYSTEM| BRK TRANSSEPTAL NEEDLE: 407201, LOT UNK| 407453, LOT UNK| SUPREME QUADRIPOLAR EP CATHETER: 401451, LOT UNK| SWARTZ BRAIDED TRANSSEPTAL INTRODUCER: