BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_LASSO

    MDR report key: 12159846 · Received July 13, 2021

    Report

    Report Number
    2029046-2021-01106
    Event Type
    Injury
    Date Received
    July 13, 2021
    Date of Event
    March 31, 2006
    Report Date
    June 25, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). 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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATIONS WERE REPORTED IN THIS PUBLICATION: IT WAS REPORTED THAT 1 PATIENT UNDERWENT CATHETER ABLATION OF ATRIAL FIBRILLATION AND SUFFERED CARDIAC TAMPONADE. INTERVENTION WAS NOT REPORTED. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS LASSO. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NONE NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: EP TRACER; CARDIOTEK. PUBLICATION DETAILS: TITLE: LEFT ATRIAL FUNCTION AFTER ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION. OBJECTIVE: THE PURPOSE OF THIS STUDY WAS TO DETERMINE WHETHER CIRCUMFERENTIAL ABLATION OF THE PULMONARY VEINS IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION (AF) WOULD AFFECT LEFT ATRIAL PERFORMANCE SHORTLY (24 HOURS) AND AT MIDTERM (6 MONTHS) FOLLOW-UP AFTER THE PROCEDURE. METHODS: WE PROSPECTIVELY STUDIED PATIENTS REFERRED FOR CATHETER ABLATION OF PAROXYSMAL AF FROM FEBRUARY 2004 TO MARCH 2006 IN THE HEART INSTITUTE HOSPITAL DAS CLINICAS-FACULDADE DE MEDICINA DA UNIVERSIDADE DE SÃO PAULO (INCOR, HCFMUSP), SÃO PAULO, BRAZIL. TO MINIMIZE THE INFLUENCE OF OTHER VARIABLES ON LEFT ATRIAL PARAMETERS, ONLY PATIENTS WITH NORMAL LEFT VENTRICULAR EJECTION FRACTION AND NO SIGNIFICANT HEART VALVE DISEASE WERE INCLUDED IN THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053099 UNK_LASSO UNK DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening