BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 4121842 · Received September 26, 2014

    Report

    Report Number
    2029046-2014-00335
    Event Type
    Death
    Date Received
    September 26, 2014
    Date of Event
    January 1, 2010
    Report Date
    September 16, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. (B)(4). PER THE ARTICLE, OTHER NON-SERIOUS AE¿S WERE ALSO REPORTED: ONE PROLONGED PERICARDIAL BLEEDING AFTER EPICARDIAL ABLATION MANAGED CONSERVATIVELY. THIS EVENT IS NOT KNOWN TO HAVE REQUIRED INTERVENTION/TREATMENT NOR EXTENDED HOSPITALIZATION STAY. IF ADDITIONAL INFORMATION IS RECEIVED, WE WILL UPDATE INFORMATION IN A SUPPLEMENTAL REPORT. THERE ARE 13 DEATH EVENTS REPORTED: PATIENT #1 DIED WITHIN 24 HOURS OF THE PROCEDURE, AS A RESULT OF A LOW-FLOW STATE ((B)(4)) PATIENT #2 DIED WITHIN 24 HOURS OF THE PROCEDURE, AS A RESULT OF LOW FLOW AND ARRHYTHMIA RECURRENCE (STATE ((B)(4)) PATIENT #3 WITH ISCHEMIC HEART DISEASE AND AN EJECTION FRACTION OF 20% DEVELOPED PULSELESS ELECTRIC ACTIVITY DURING REINTERVENTION STATE ((B)(4)) PATIENT #4 DIED OF HEART FAILURE AT 10 DAYS STATE ((B)(4)) PATIENT #5 DIED OF HEART FAILURE AT 6 MONTHS STATE ((B)(4)) PATIENT #6 PATIENT WITHOUT AN ICD DIED SUDDENLY AT 5 WEEKS STATE ((B)(4)) PATIENT #7 DIED AT 30 MONTHS OF VT STORM STATE ((B)(4)) SIX OTHER PATIENTS DIED OF NONCARDIAC CAUSES UNRELATED TO THE PROCEDURE FROM 20 DAYS TO 40 MONTHS AFTER INTERVENTION. THERE ARE NO DEVICE MALFUNCTIONS REPORTED IN THE PUBLICATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS THE NAVISTAR THERMOCOOL. OTHER BW DEVICES USED IN SOME OF THE PROCEDURES: PENTARAY AND NAVISTAR CATHETERS. THIS REPORT COVERS PATIENT #1 OF THE ARTICLE: PATIENT #1 DIED WITHIN 24 HOURS OF THE PROCEDURE, AS A RESULT OF A LOW-FLOW STATE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS TO DOCUMENT PATIENT #7 (DEATH EVENT) FROM THE LITERATURE ARTICLE ((B)(4)): ARTICLE TITLE: ELIMINATION OF LOCAL ABNORMAL VENTRICULAR ACTIVITIES: A NEW END POINT FOR SUBSTRATE MODIFICATION IN PATIENTS WITH SCAR-RELATED VENTRICULAR TACHYCARDIA. PER A REPORT IN THE JOURNAL OF CIRCULATION. (B)(6) MAY 8;125(18):2184-96, A [MULTI/SINGLE]-CENTER [CONTROLLED/RANDOMIZED/DOUBLE-BLIND,ETC.] STUDY WAS CONDUCTED ON 70 PATIENTS, BY JAÏS P OF THE HOPITAL HAUT-LEVEQUE, BORDEAUX-PESSAC, FRANCE ET AL., TO ASSESS IF ELIMINATION OF LOCAL ABNORMAL VENTRICULAR ACTIVITIES (LAVAS) RECORDED DURING SINUS RHYTHM OR VENTRICULAR PACING WOULD BE FEASIBLE AS AN END POINT FOR VT ABLATION AND THAT COMPLETE ELIMINATION OF LAVAS WOULD LEAD TO A REDUCTION IN ARRHYTHMIA-FREE SURVIVAL. MEDIAN FOLLOW UP TIME OF 22 MONTHS. FROM THE REPORT THERE WERE 3 SERIOUS ADVERSE EVENTS: ATRIAL FIBRILLATION REQUIRING ANTICOAGULATION WITH LATE DEVELOPMENT OF TAMPONADE MANAGED CONSERVATIVELY; ((B)(4)) RIGHT VENTRICULAR PERFORATION REQUIRING SURGICAL REPAIR; ((B)(4)) TAMPONADE DURING ENDOCARDIAL ABLATION MANAGED CONSERVATIVELY. (MANUFACTURER (B)4))

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601828 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 67 YR Death| L