BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK_NAVISTAR

    MDR report key: 8121235 · Received November 30, 2018

    Report

    Report Number
    2029046-2018-02361
    Event Type
    Death
    Date Received
    November 30, 2018
    Date of Event
    December 31, 2015
    Report Date
    November 6, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 LOT NUMBER WAS PROVIDED BY THE CUSTOMER. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NONE. MANUFACTURER'S REF. NO: (B)(4). BIOSENSE WEBSTER MANUFACTURER'S REPORT NUMBERS: 2029046-2018-02360 ARE RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATIONS WERE REPORTED IN THIS PUBLICATION: 1 PATIENT WITH HYPERTROPHIC CARDIOMYOPATHY (HCM) AND LEFT VENTRICULAR APICAL ANEURYSM (AA) UNDERWENT CATHETER ABLATION OF VENTRICULAR TACHYCARDIA USING NAVISTAR CATHETER AND DIED 17 DAYS POST PROCEDURE. ALTHOUGH THE CAUSE OF DEATH WAS UNKNOWN, IT WAS POSSIBLY CAUSED BY LATE CARDIAC TAMPONADE OR FATAL VENTRICULAR ARRHYTHMIA. NO FURTHER DETAILS WERE PROVIDED. MULTIPLE REQUESTS FOR CLARIFICATION HAVE BEEN SENT TO THE CORRESPONDING AUTHOR, BUT NO ADDITIONAL DETAILS WERE PROVIDED AT THIS TIME. IF ADDITIONAL DETAILS WILL BE PROVIDED THIS REPORT WILL BE UPDATED ACCORDINGLY. THERE ARE 1 DEATH EVENTS AND 0 DEVICE MALFUNCTIONS REPORTED IN THIS PUBLICATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE ARE THERMOCOOL SMARTTOUCH AND NAVISTAR. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO, CARTOSOUND, PENTARAY, DECANAV. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ABLAZE (LIFELINE INC.). PUBLICATION DETAILS: TITLE: RADIOFREQUENCY CATHETER ABLATION OF VENTRICULAR TACHYCARDIA IN PATIENTS WITH HYPERTROPHIC CARDIOMYOPATHY AND APICAL ANEURYSM. OBJECTIVE: TO EVALUATE THE CHARACTERISTICS AND RESULTS OF RADIOFREQUENCY CATHETER ABLATION (RFCA) OF VENTRICULAR TACHYCARDIA (VT) IN PATIENTS WITH HYPERTROPHIC CARDIOMYOPATHY (HCM) AND LEFT VENTRICULAR APICAL ANEURYSM (AA). METHODS: FIFTEEN PATIENTS WITH HCM AND AA WHO UNDERWENT RFCA FOR VT AT 5 DIFFERENT INSTITUTIONS BETWEEN JANUARY 2005 TO DECEMBER 2015 WERE INCLUDED IN THIS STUDY. THE DATA WERE EVALUATED RETROSPECTIVELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961230 UNK_NAVISTAR UNK_NAVISTAR LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death