BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ STEER THERMOCOOL NAV 4MM

    MDR report key: 3725828 · Received April 3, 2014

    Report

    Report Number
    9673241-2014-00128
    Event Type
    Death
    Date Received
    April 3, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 27, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BWI EQUIPMENT IN USE: CARTO3 SYSTEM SN: (B)(4). STOCKERT (SERIAL # UNKNOWN). COOLFLOW PUMP (SERIAL # UNKNOWN). THE MANUFACTURER REF# (B)(4) ARE RELATED TO THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    IN THE INITIAL REPORT WAS MENTIONED THE EVENT WAS DEATH CASE HOWEVER UPON FOLLOW UP, BWI RECEIVED THE INFORMATION ON APRIL 09, 2014 THAT SHOWED THE EVENT WAS SERIOUS INJURY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN AFIB ¿ PAROXYSMAL PROCEDURE A PATIENT SUFFERED AN ESOPHAGEAL FISTULA, DIAGNOSED APPROXIMATELY 2 WEEKS POST PROCEDURE AND PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201917 EZ STEER THERMOCOOL NAV 4MM CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) GENERIC - EZ STEER NAV (TC) UNKNOWN_D-1292-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Death