BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 6661082 · Received June 22, 2017

    Report

    Report Number
    2029046-2017-00209
    Event Type
    Injury
    Date Received
    June 22, 2017
    Date of Event
    September 30, 2014
    Report Date
    June 1, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS THAT USED IN THIS STUDY: CARTO MERGE. OTHER COMPANIES DEVICES THAT USED IN THIS STUDY: LIBERO, ULTIMUM AGILIS, ESOPHASTAR, DELTA OHM. MANUFACTURER'S REF. NO: (B)(4). THE DEVICE IS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 217 PATIENTS UNDERWENT A BOX ISOLATION OF NONPAROXYSMAL AF BETWEEN OCTOBER 2011 AND SEPTEMBER 2014. AMONG THEM, 1 PATIENT HAD CONGESTIVE HEART FAILURE IN THE PBI GROUP. BASED ON THE FACTS OF THE CASE AND THE AUTHOR¿S ASSESSMENT, THERE WERE NO REPORTED MALFUNCTION WITH ANY OF THE BWI CATHETERS AND SYSTEMS USED DURING THE CASE. THUS, THIS EVENT IS UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE. TITLE: ¿IS IT NECESSARY TO ACHIEVE A COMPLETE BOX ISOLATION IN THE CASE OF FREQUENT ESOPHAGEAL TEMPERATURE RISES? FEASIBILITY OF SHIFTING TO A PARTIAL BOX ISOLATION STRATEGY FOR PATIENTS WITH NON-PAROXYSMAL ATRIAL FIBRILLATION.¿ THE AIM OF THIS STUDY WAS TO EVALUATE THE FEASIBILITY OF THIS PBI STRATEGY IN CASES WITH FREQUENT LET RISES AND NON-PAF. SUSPECT DEVICE IS A NAVISTAR THERMOCOOL, HOWEVER CATALOG AND LOT NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440784 NAVISTAR® THERMOCOOL® SIMILAR DEVICE NI75TCJH, PMA # P030031 OAD BIOSENSE WEBSTER, INC. (IRWINDALE) D-1197-00 UNKNOWN_NAVISTAR THERMO TC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other