BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 11258059 · Received February 1, 2021

    Report

    Report Number
    11258059
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    November 5, 2020
    Report Date
    January 13, 2021
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE ARE REPORTING A TOTAL OF (B)(4) EVENTS WITH DIFFERENT MODELS OF ELECTROPHYSIOLOGICAL ABLATION CATHETERS BY BIOSENSE WEBSTER, WHICH OCCURRED IN THE PAST YEAR. IN THIS REPORT, WE HAVE LISTED 01 EVENT OUT OF THE 41 EVENTS. THE DETAILS ARE BELOW: MODEL/CATALOG #: D133601, LOT NUMBER: 30417972M. BRAND NAME: MALFUNCTION NAVISTAR THERMOCOOL CATHETERS, BROKEN SPRING MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154936 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. D133601 30417972M

    Patients

    Seq Age Sex Outcome Treatment
    1