BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_LASSO

    MDR report key: 10538297 · Received September 15, 2020

    Report

    Report Number
    2029046-2020-01248
    Event Type
    Injury
    Date Received
    September 15, 2020
    Date of Event
    February 28, 2005
    Report Date
    August 28, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. BIOSENSE WEBSTER MANUFACTURER'S REPORT NUMBERS: 2029046-2020-01247, 2029046-2020-01250. 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: IT WAS REPORTED THAT 2 PATIENTS UNDERWENT CATHETER ABLATION OF ATRIAL FIBRILLATION AND SUFFERED CARDIAC TAMPONADE. 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. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NONE NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARDIOLAB SYSTEM, IRVINE BIOMEDICAL INC CATHETER, SR0 SHEATH, MULLINS TRANSSEPTAL SHEATH, JAPAN LIFELINE INC ABLATION CATHETER, A DELTA OHM THERMOCOUPLE THERMOMETER. PUBLICATION DETAILS: TITLE: SAFE AND EFFECTIVE ABLATION OF ATRIAL FIBRILLATION: IMPORTANCE OF ESOPHAGEAL TEMPERATURE MONITORING TO AVOID PERIESOPHAGEAL NERVE INJURY AS A COMPLICATION OF PULMONARY VEIN ISOLATION. OBJECTIVE: . THIS STUDY AIMED TO EVALUATE THE EFFICACY OF ESOPHAGEAL TEMPERATURE MONITORING (ETM) IN PREVENTING SUCH ESOPHAGUS-RELATED COMPLICATIONS IN PATIENTS WITH DRUG-REFRACTORY AF UNDERGOING PULMONARY VEIN (PV) ISOLATION. METHODS: THIS STUDY INCLUDED A TOTAL OF 359 CONSECUTIVE PATIENTS WITH DRUG-REFRACTORY AF (239 PAROXYSMAL AND 120 PERSISTENT AF) WHO UNDERWENT PV ISOLATION IN OUR LABORATORY BETWEEN JULY 2003 AND FEBRUARY 2006. AF WAS CLASSIFIED AS PAROXYSMAL IF EPISODES TERMINATED SPONTANEOUSLY IN LESS THAN 7 DAYS, AND AS PERSISTENT IF IT FAILED TO SELF-TERMINATE WITHIN 7 DAYS. ALL PATIENTS WERE DIVIDED INTO TWO GROUPS: THE NON-ETM GROUP, WHICH WAS COMPRISED OF THE FIRST 152 PATIENTS UNDERGOING. THE ABLATION PROCEDURE WITHOUT ETM, AND THE ETM GROUP, WHICH CONSISTED OF THE LAST 207 PATIENTS TREATED WITH ETM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001328 UNK_LASSO UNK DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R