BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_LASSO

    MDR report key: 10540957 · Received September 16, 2020

    Report

    Report Number
    2029046-2020-01246
    Event Type
    Injury
    Date Received
    September 16, 2020
    Date of Event
    June 30, 2002
    Report Date
    August 28, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 1 PATIENT UNDERWENT CATHETER ABLATION AND SUFFERED MODERATE PULMONARY VEIN STENOSIS 50-70%. INTERVENTION WAS NOT REPORTED. 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: (ACUNAVE - ACUSON, A COOL-TIPPED ABLATION CATHETER - EP TECHNOLOGIES. PUBLICATION DETAILS: TITLE: RANDOMIZED STUDY COMPARING COMBINED PULMONARY VEIN-LEFT ATRIAL JUNCTION DISCONNECTION AND CAVOTRICUSPID ISTHMUS ABLATION VERSUS PULMONARY VEIN-LEFT ATRIAL JUNCTION DISCONNECTION ALONE IN PATIENTS PRESENTING WITH TYPICAL ATRIAL FLUTTER AND ATRIAL FIBRILLATION. OBJECTIVE: ¿ATRIAL FLUTTER (AFL) AND ATRIAL FIBRILLATION (AF) FREQUENTLY COEXIST IN THE SAME PATIENT. RECENTLY IT HAS BEEN DEMONSTRATED THAT THE TRIGGERS FOR BOTH AF AND AFL MAY ORIGINATE IN THE PULMONARY VEINS (PVS). WE HYPOTHESIZED THAT IN PATIENTS WITH BOTH AF AND TYPICAL AFL, PULMONARY VEIN¿LEFT ATRIAL JUNCTION (PV-LAJ) DISCONNECTION MAY ELIMINATE BOTH ARRHYTHMIAS. METHODS: CONSECUTIVE PATIENTS WITH DOCUMENTED SYMPTOMATIC AF AND TYPICAL AFL WERE RANDOMLY ASSIGNED TO HAVE PV-LAJ DISCONNECTION COMBINED WITH CAVOTRICUSPID ISTHMUS (CTI) ABLATION (GROUP 1, N49) OR PV-LAJ DISCONNECTION ALONE (GROUP 2, N59).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007141 UNK_LASSO UNK DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other