BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK_NAVISTAR RMT THERMOCOOL

    MDR report key: 10047956 · Received May 12, 2020

    Report

    Report Number
    2029046-2020-00596
    Event Type
    Death
    Date Received
    May 12, 2020
    Date of Event
    January 1, 2019
    Report Date
    April 22, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿RADIOFREQUENCY-ASSISTED TRANSSEPTAL ACCESS FOR ATRIAL FIBRILLATION ABLATION VIA A SUPERIOR APPROACH.¿ A PATIENT WITH ATRIAL FIBRILLATION WHO UNDERWENT ABLATION PROCEDURE (SUPERIOR VENA CAVA ISOLATION) VIA A SUPERIOR APPROACH (PULMONARY VEINS AND POSTERIOR WALL ISOLATED FROM THE PREVIOUS EPICARDIAL PROCEDURE) DIED OF ATRIOESOPHAGEAL FISTULA, WHICH WAS LIKELY UNRELATED TO THE SUPERIOR ACCESS AF ABLATION. THIS PATIENT HAD ALREADY UNDERGONE SURGICAL EPICARDIAL-ONLY ABLATION (PVI AND POSTERIOR WALL ISOLATION) AS PART OF A HYBRID APPROACH AND WAS BROUGHT BACK 3 WEEKS LATER FOR ENDOCARDIAL ABLATION VIA SUPERIOR ACCESS. THE FISTULA WAS INCIDENTALLY ENGAGED DURING THE SUPERIOR ACCESS PROCEDURE USING THE REMOTE MAGNETIC NAVIGATION SYSTEM AND BEFORE DELIVERING ANY ABLATION LESIONS FROM THE ENDOCARDIAL LA. FOLLOWING THE PROCEDURE, HE DEVELOPED SUDDEN BLINDNESS, MELENA AND SEPSIS, AND AN ATRIOESOPHAGEAL FISTULA WAS DIAGNOSED WITH COMPUTED TOMOGRAPHIC IMAGING. THE PATIENT WAS TREATED WITH AN ESOPHAGEAL STENT; HOWEVER, HE DIED ON POSTOPERATIVE DAY 1 DUE TO PROGRESSION OF STROKE AND SEPSIS. OBJECTIVES: THIS STUDY DESCRIBES THE TECHNIQUE AND OUTCOMES OF ATRIAL FIBRILLATION (AF) ABLATION VIA A SUPERIOR APPROACH IN PATIENTS WITH INTERRUPTED OR ABSENT INFERIOR VENA CAVAS (IVCS). METHODS: THIS STUDY IDENTIFIED PATIENTS WITH INTERRUPTED OR ABSENT IVCS WHO UNDERWENT AF ABLATION VIA A SUPERIORAPPROACH AT 2 ABLATION CENTERS FROM 2010 TO 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510881 UNK_NAVISTAR RMT THERMOCOOL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death