BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_LASSO

    MDR report key: 8750874 · Received July 1, 2019

    Report

    Report Number
    2029046-2019-03374
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    January 31, 2011
    Report Date
    June 10, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER'S REF. (B)(4). BIOSENSE WEBSTER MANUFACTURER'S REPORT NUMBERS: 2029046-2019-03373, 2029046-2019-03374, 2029046-2019-03375 ARE RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATIONS WERE REPORTED IN THIS PUBLICATION: 1 PATIENT UNDERWENT CATHETER ABLATION OF ATRIAL FIBRILLATION AND SUFFERED CORONARY AIR EMBOLISM. NO ADDITIONAL DETAILS WERE PROVIDED. MULTIPLE REQUESTS FOR CLARIFICATION HAVE BEEN SENT TO THE CORRESPONDING AUTHOR, BUT NO ADDITIONAL DETAILS WERE PROVIDED AT THIS TIME. IF ADDITIONAL DETAILS WILL BE PROVIDED THIS REPORT WILL BE UPDATED ACCORDINGLY. THERE ARE 0 DEATH EVENTS AND 0 DEVICE MALFUNCTIONS REPORTED IN THIS PUBLICATION. 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: NAVX SYSTEM (ST. JUDE MEDICAL, INC.), DUO-DECAPOLAR (ST. JUDE MEDICAL, INC., MINNETONKA, MN, USA) AND DECAPOLAR (BARD ELECTROPHYSIOLOGY, INC., LOWELL, MA, USA), (FAST-CATHTM SWARTZTM),ST JUDE MEDICAL, AF DIVISION, MINNETONKA, MN, USA). TITLE: COMPARISON BETWEEN LINEAR AND FOCAL ABLATION OF COMPLEX FRACTIONATED ATRIAL ELECTROGRAMS IN PATIENTS WITH NON-PAROXYSMAL ATRIAL FIBRILLATION: A PROSPECTIVE RANDOMIZED TRIAL. OBJECTIVE: TO COMPARE CLINICAL OUTCOMES OF COMPLEX FRACTIONATED ATRIAL ELECTROGRAM (CFAE)-GUIDED FOCAL ABLATION (CFA) AND CFAE-GUIDED LINEAR ABLATION (CLA) IN PATIENTS WITH NON-PAROXYSMAL AF. PATIENTS WERE ENROLLED BETWEEN JANUARY 2009 AND AUGUST 2011. 150 PATIENTS WITH NON-PAROXYSMAL AF INTO CFA AND CLA GROUPS IN A 1:1 RATIO. COMPLEX FRACTIONATED ATRIAL ELECTROGRAM DISTRIBUTION WAS EVALUATED USING AN AUTOMATED ALGORITHM OF A THREE-DIMENSIONAL MAPPING SYSTEM. AFTER PULMONARY VEIN ISOLATION (PVI), CFAE-GUIDED ABLATION WAS PERFORMED IN THE LEFT ATRIUM AND THEN IN THE RIGHT ATRIUM (RA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544043 UNK_LASSO UNK DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening