BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_NAVISTAR THERMOCOOL

    MDR report key: 8112373 · Received November 28, 2018

    Report

    Report Number
    2029046-2018-02357
    Event Type
    Injury
    Date Received
    November 28, 2018
    Date of Event
    February 28, 2016
    Report Date
    November 5, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. CONCOMITANT PRODUCTS THAT USED IN THIS STUDY: CARTO, THERMOCOOL SMARTTOUCH, THERMOCOOL SMARTTOUCH SF. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NONE. (B)(4). BIOSENSE WEBSTER MANUFACTURER'S REPORT NUMBERS: 2029046-2018-02356, 2029046-2018-02357, ARE RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    "EVENT DESCRIPTION: THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATIONS WERE REPORTED IN THIS PUBLICATION: 2 PATIENTS UNDERWENT CATHETER ABLATION OF VENTRICULAR TACHYCARDIA AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. 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 IS 1 DEATH EVENT AND 0 DEVICE MALFUNCTIONS REPORTED IN THIS PUBLICATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS NAVISTAR THERMOCOOL OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NONE. PUBLICATION DETAILS TITLE: TARGETING THE HIDDEN SUBSTRATE UNMASKED BY RIGHT VENTRICULAR EXTRASTIMULATION IMPROVES VENTRICULAR TACHYCARDIA ABLATION OUTCOME AFTER MYOCARDIAL INFARCTION OBJECTIVE: TO DETERMINE WHETHER ABLATION OF HIDDEN SUBSTRATE UNMASKED BY RIGHT VENTRICULAR EXTRASTIMULATION (RVE) IMPROVES ABLATION OUTCOME OF POST-MYOCARDIAL INFARCTION (MI) VENTRICULAR TACHYCARDIA (VT). METHODS: BETWEEN OCTOBER 2013 AND FEBRUARY 2016, 60 CONSECUTIVE PATIENTS UNDERWENT SYSTEMATIC ANALYSIS OF ELECTROGRAMS RECORDED FROM THE PRESUMED INFARCT AREA DURING SINUS RHYTHM, RIGHT VENTRICLE (RV) PACING AT 500 MS, AND DURING A SHORT-COUPLED RV EXTRASTIMULUS. SITES SHOWING LOW VOLTAGE,NEAR-FIELD POTENTIALS WITH EVOKED CONDUCTION DELAY IN RESPONSE TO RVE WERE TARGETED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951390 UNK_NAVISTAR THERMOCOOL UNK_NAVISTAR THERMOCOOL OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening