BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL SMARTTOUCH SF BI-DIRECT NAV DF

    MDR report key: 19370923 · Received May 21, 2024

    Report

    Report Number
    MW5155184
    Event Type
    Death
    Date Received
    May 21, 2024
    Date of Event
    January 31, 2022
    Report Date
    May 18, 2024
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    LPB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CARDIAC ABLATION PERFORMED USING (B)(6) THERMOCOOL SMARTTOUCH SF BI-DIRECT NAV DF CATHETER PATIENT DEATH DUE TO HYPOXIC RESPIRATORY FAILURE DUE TO SEPTIC SHOCK DUE TO ATRIAL ESOPHAGEAL FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704732 THERMOCOOL SMARTTOUCH SF BI-DIRECT NAV DF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death