BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ STEER? THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3430548 · Received October 25, 2013

    Report

    Report Number
    9673241-2013-00369
    Event Type
    Death
    Date Received
    October 25, 2013
    Date of Event
    October 9, 2013
    Report Date
    October 9, 2013
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3 MODEL# M-4800-01 SERIAL# (B)(4); STOCKERT MODEL# M-5463-01 SERIAL# (B)(4); COOLFLOW PUMP MODEL# M-5491-02 SERIAL# (B)(4); PENTARAY NAV MODEL# D-1282-04-S LOT# 15785580L. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE VENTRICULAR TACHYCARDIA CASE, THE PATIENT'S BLOOD PRESSURE DROPPED. A STAT ECHO WAS CALLED AND THE PHYSICIAN DETECTED TAMPONADE. LATER ON IT WAS NOTICED THAT THE PATIENT EXPIRED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549116 EZ STEER? THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1292-05-S 15920264M

    Patients

    Seq Age Sex Outcome Treatment
    1 Death