BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_LASSO

    MDR report key: 10736938 · Received October 26, 2020

    Report

    Report Number
    2029046-2020-01538
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    February 8, 2019
    Report Date
    October 8, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    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 2 PATIENTS UNDERWENT CATHETER ABLATION OF ATRIAL FIBRILLATION AND SUFFERED LARGE GROIN HEMATOMA PROLONGING THE HOSPITALIZATION FOR 2 AND 3 DAYS, RESPECTIVELY. BOTH WERE TREATED CONSERVATIVELY WITHOUT CONSEQUENCES. 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 OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO3 NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ACUNAV ULTRASOUND CATHETER, INQUIRY¿, AGILIS SHEATHS, LA USING CARTOMERGE, PUBLICATION DETAILS TITLE: ATRIAL FIBRILLATION INDUCIBILITY AFTER PULMONARY VEIN ISOLATION UNDER GENERAL ANAESTHESIA OBJECTIVE: ATRIAL FIBRILLATION (AF) INDUCIBILITY WITH RAPID ATRIAL PACING FOLLOWING AF ABLATION IS ASSOCIATED WITH HIGHER RISK OF AF RECURRENCE. THE PREDICTIVE VALUE OF AF INDUCIBILITY IN PAROXYSMAL AF PATIENTS AFTER PULMONARY VEIN ISOLATION (PVI), DONE UNDER GENERAL ANAESTHESIA (GA), REMAINS QUESTIONABLE SINCE GA MIGHT ALTER AF INDUCIBILITY AND/OR SUSTAINABILITY METHODS: CONSECUTIVE PATIENTS (N = 120) WITH PAROXYSMAL AF WITHOUT PRIOR CATHETER ABLATION (CA) WERE ENLISTED IN THE STUDY. ALL PATIENTS WERE ABLATED UNDER GA. WE HAVE USED A POINT-BY-POINT CA AND ELIMINATION OF DORMANT CONDUCTION AFTER ADENOSINE IN ALL PATIENTS. A PREDEFINED STIMULATION PROTOCOL WAS USED TO INDUCE ARRHYTHMIAS AFTER PVI. REGULAR SUPRAVENTRICULAR TACHYCARDIAS WERE MAPPED AND ABLATED. PATIENTS WERE DIVIDED INTO 3 SUBGROUPS ¿ NONINDUCIBLE, INDUCIBLE AF WITH SPONTANEOUS TERMINATION IN FIVE MINUTES, INDUCIBLE AF WITHOUT SPONTANEOUS TERMINATION. DURING 12 MONTHS OF FOLLOW-UP, ALL PATIENTS WERE EXAMINED FOUR-TIMES WITH 7-DAY ECG RECORDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201336 UNK_LASSO UNK DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization