BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 11258063 · Received February 1, 2021

    Report

    Report Number
    11258063
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    February 11, 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 (B)(4) EVENT OUT OF THE (B)(4) EVENTS. THE DETAILS ARE BELOW: BRAND NAME: SMART TOUCH BI-DIRECTIONAL CATHETER. MODEL/CATALOG #: D132705, LOT NUMBER: 30280891M, MALFUNCTION: MALFUNCTION: 106 FORCE SENSOR ERROR. D132705, 30283510M, MAP SENSOR ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154941 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. D132705 30280891M AND 30283510M

    Patients

    Seq Age Sex Outcome Treatment
    1