BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 6012488 · Received October 7, 2016

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    Report

    Report Number
    2029046-2016-00207
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    July 31, 2016
    Report Date
    September 15, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. EVALUATION METHODS: NO TESTING METHODS PERFORMED; (B)(4). RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED; (B)(4). CONCLUSION: DEVICE DISCARDED BY USER, UNABLE TO FOLLOW-UP; (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 10/20/2016: ALL ADVERSE EVENTS WERE POSSIBLY RELATED TO THE PROCEDURE. THE EVENT DID NOT RESULT IN THE IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE. THE CATHETER USED IN THIS PROCEDURE WAS NOT A REPROCESSED / REUSED CATHETER. ALL PATIENTS ARE FULLY RECOVERED. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 37 PATIENTS FROM THE PLACEBO GROUP UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE USING A THERMOCOOL CATHETER AND SUFFERED EPIGASTRIC DISTRESS. BASED ON THE FACTS OF THE CASE AND THE AUTHOR¿S ASSESSMENT, THERE WERE NO REPORTED MALFUNCTION WITH ANY OF THE BWI SYSTEMS USED DURING THE CASE. THUS, THIS EVENT IS UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE. TITLE: ¿PERINDOPRIL FOR THE PREVENTION OF ATRIAL FIBRILLATION RECURRENCE AFTER RADIOFREQUENCY CATHETER ABLATION: ONE-YEAR EXPERIENCE.¿ THE PURPOSE OF THIS STUDY WAS TO PROVE THAT PERINDOPRIL (8 MG) COULD PREVENT RECURRENCE ATRIAL FIBRILLATION AFTER PULMONARY VEIN ISOLATION. TWO HUNDRED FIFTY SIX (256) PATIENTS WERE ENROLLED IN THIS STUDY. THE SUSPECTED DEVICE IS THE THERMOCOOL ABLATION CATHETER, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661945 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 60 YR Other