BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 20757100 · Received November 22, 2024

    Report

    Report Number
    20757100
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    October 4, 2024
    Report Date
    November 13, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SVT ABLATION AT (B)(6) ON [REDACTED DATE]. THE ABLATION CATHETER HAD A SENSOR ERROR. MANUFACTURER RESPONSE FOR NAVIGATION DEVICE, THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER NAV ST SF D (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777526 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 31220606L

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose