BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH?

    MDR report key: 3629000 · Received February 14, 2014

    Report

    Report Number
    9673241-2014-00052
    Event Type
    Injury
    Date Received
    February 14, 2014
    Date of Event
    May 7, 2013
    Report Date
    January 27, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO [THERMOCOOL SF NAV] APPROVED UNDER [P030031/S034]. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, AT THE TIME OF CREATING THE CARTO MAP, THE PHYSICIAN NOTICED A CARDIAC PEFORATION. THIS CASE WAS PART OF CLINICAL STUDY AND IT WAS PROCEDURE RELATED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97307 THERMOCOOL® SMART TOUCH? OAE BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-02-S UNKNOWN_D-1336-02-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R