BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER

    MDR report key: 5151641 · Received October 15, 2015

    Report

    Report Number
    9673241-2015-00747
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    July 31, 2015
    Report Date
    September 24, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. THE DEVICE HISTORY RECORD (DHR) HAS BEEN REVIEWED AND IT WAS VERIFIED THAT DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. 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 SMART TOUCH UNIDIRECTIONAL APPROVED UNDER P030031/S053. (B)(4). METHODS: NO TESTING METHODS PERFORMED. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: DEVICE DISCARDED BY USER, UNABLE TO FOLLOW-UP. (B)(4) THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS EVENT IS PART OF SMART-SF CLINICAL STUDY. IT WAS REPORTED THAT A (B)(6) MALE PATIENT WITH A MEDICAL HISTORY OF SYMPTOMATIC ATRIAL FIBRILLATION UNDERWENT A PULMONARY VEIN ISOLATION PROCEDURE USING A SMARTTOUCH THERMOCOOL SF CATHETER. THE PATIENT DEVELOPED NEW ONSET ATRIAL FLUTTER WHICH REQUIRED MEDICATION, PHARMACOLOGICAL CARDIOVERSION LESS THAN 7 DAYS POST PROCEDURE. THE ISSUE WAS RESOLVED WITHOUT SEQUELAE. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS NOT DEVICE RELATED AND POSSIBLY PROCEDURE RELATED. THE AWARENESS DATE FOR THIS RECORD IS 09/24/2015 BECAUSE BWI BECAME AWARE OF THIS EVENT ON 09/24/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684448 THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1347-02-SI 17235806L

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R