BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 4922638 · Received July 17, 2015

    Report

    Report Number
    2029046-2015-00190
    Event Type
    Death
    Date Received
    July 17, 2015
    Date of Event
    December 31, 2012
    Report Date
    June 25, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CANNOT BE PROVIDED. CONCOMITANT PRODUCTS WERE USED DURING THIS STUDY: CARTO 3 MAPPING SYSTEM. (B)(4). THE DEVICES WERE NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT SEVEN PATIENTS DIED FROM CARDIAC CAUSES DURING THE STUDY PERIOD (SIX DUE TO CARDIAC DECOMPENSATION AND ONE SUDDEN DEATH). ALL PATIENTS UNDERWENT VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE DATES OF DEATHS (DURING ABLATION PROCEDURE OR FOLLOW-UP) WERE UNKNOWN. BWI TAKES CONSERVATIVE APPROACH TO REPORT THE EVENTS. 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, THESE EVENTS ARE UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE. OTHER ADVERSE EVENTS REPORTED IN THE ARTICLE: - 5 PATIENTS DIED FROM NON-CARDIAC CAUSES (BWI WILL NOT OPEN COMPLAINTS FOR THESE EVENTS AS THEY ARE NOT PROCEDURE RELATED OR DEVICE RELATED). TITLE: ¿ELECTROANATOMICAL VOLTAGE AND MORPHOLOGY CHARACTERISTICS IN POST-INFARCTION PATIENTS UNDERGOING VENTRICULAR TACHYCARDIA ABLATION: A PRAGMATIC APPROACH FAVORING LATE POTENTIALS ABOLITION¿. THE PURPOSE OF THIS STUDY WAS TO ANALYZE THE ENDO-EPICARDIAL ELECTROANATOMICAL MAPPING (EAM) VOLTAGE AND MORPHOLOGY CHARACTERISTICS IN ORDER TO DESCRIBE THE APPROPRIATENESS OF EACH SUBSTRATE ABLATION STRATEGY, THE INTERRELATIONSHIP OF EAM CHARACTERISTICS, THEIR ASSOCIATION WITH CLINICAL DATA AND THEIR PROGNOSTIC VALUE IN A LARGE COHORT OF POST-MI PATIENTS UNDERGOING EAM-BASED CATHETER ABLATION FOR VT. THE STUDY WAS CONDUCTED JANUARY 2010 AND DECEMBER 2012. SUSPECTED DEVICE IS NAVISTAR THERMOCOOL, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464677 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 70 YR Death