BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_NAVISTAR

    MDR report key: 11803318 · Received May 10, 2021

    Report

    Report Number
    2029046-2021-00735
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    January 31, 2020
    Report Date
    April 21, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. BIOSENSE WEBSTER MANUFACTURER'S REPORT NUMBER: 2029046-2021-00737 IS 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 1 PATIENT UNDERWENT CATHETER ABLATION OF ATRIAL FIBRILLATION AND SUFFERED TAMPONADE. INTERVENTION WAS STERNOTOMY. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS NAVIS-TAR OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NONE. PUBLICATION DETAILS TITLE: NEW HOPE FOR PATIENTS AND CHALLENGES FOR THE MULTIDISCIPLINARY ARRHYTHMIA TEAM: A HYBRID CONVERGENT APPROACH FOR ATRIAL FIBRILLATION TREATMENT OBJECTIVE: THIS STUDY AIMED TO ASSESS THE PERIPROCEDURAL SAFETY AS WELL AS ACUTE AND LONG-TERM OUTCOMES OF HABL FOR AF. METHODS: THIS IS A RETROSPECTIVE SINGLE-CENTER STUDY OF PATIENTS WHO UNDERWENT HABL USING THE MINIMALLY INVASIVE TRANSABDOMINAL APPROACH BETWEEN JULY 2009 AND JANUARY 2020. DEMOGRAPHIC IN-HOSPITAL DATA AND 12-MONTH FOLLOW-UP RESULTS WERE OBTAINED. THE NUMBER OF HOSPITALIZATIONS, CARDIOVERSIONS, RE-ABLATIONS, AND SEVERE ADVERSE EVENTS IN A 3-YEAR PERIOD BEFORE AND AFTER HABL WERE COMPARED USING DATA FROM THE NATIONAL HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694632 UNK_NAVISTAR UNK OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R UNK_CARTO 3