BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 6067160 · Received October 31, 2016

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    Report

    Report Number
    2029046-2016-00237
    Event Type
    Injury
    Date Received
    October 31, 2016
    Date of Event
    September 30, 2015
    Report Date
    October 11, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    LPB
    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 WERE USED DURING THIS STUDY: CARTO MAPPING SYSTEM, LASSO CATHETER OTHER COMPANY¿S DEVICES WERE USED DURING THIS STUDY: THERMOMETER (SENSITHERMO, ST. JUDE MEDICAL) (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 110 PATIENTS WITH PAROXYSMAL OR PERSISTENT AF UNDERWENT ABLATION FOR AF. COMPLICATION RELATED TO AF ABLATION WAS OBSERVED: ONE PATIENT HAD AIR EMBOLISM. 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: "FIBRILLATORY PATTERN OF DISSOCIATED VENOUS ACTIVITY AFTER PULMONARY VEIN ISOLATION: NOVEL CHARACTERISTICS FOR REMNANT FOCI OF A TRIGGER ECTOPY FOR ATRIAL FIBRILLATION." THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE CORRELATION BETWEEN DPVA AND THE PV TRIGGERS OF ATRIAL FIBRILLATION (AF). SUSPECTED DEVICE IS NAVISTAR THERMOCOOL ABLATION CATHETER, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717916 NAVISTAR® THERMOCOOL® SIMILAR DEVICE NI75TCJH, PMA # P030031 LPB BIOSENSE WEBSTER, INC. (IRWINDALE) D-1197-00 UNKNOWN_NAVISTAR THERMO TC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening