BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 6570221 · Received May 16, 2017

    Report

    Report Number
    2029046-2017-00162
    Event Type
    Death
    Date Received
    May 16, 2017
    Date of Event
    October 31, 2015
    Report Date
    April 20, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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: CARTO MAPPING SYSTEM, LASSO CATHETER. OTHER COMPANIES¿ DEVICES WERE USED IN THIS STUDY: A 64-POLE BASKET CATHETER (CONSTELLATION, BOSTON SCIENTIFIC), FIRM (ABBOTT ELECTROPHYSIOLOGY). MANUFACTURER'S REF. NO: (B)(4) THE DEVICE IS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 170 CONSECUTIVE PATIENTS WITH PAF (37%), PERSISTENT ATRIAL FIBRILLATION (PEAF) (31%), LONG-STANDING PERSISTENT ATRIAL FIBRILLATION (LPEAF) (32%), OR PAROXYSMAL ATRIAL FIBRILLATION (PAF) (37%) UNDERWENT CATHETER ABLATION FROM JANUARY 2012 TO OCTOBER 2015. THIS IS IU-FIRM REGISTRY AND FOCAL IMPULSE AND ROTOR MODULATION (FIRM) WITH AN ENDOCARDIAL BASKET CATHETER WAS USED IN ALL CASES. AMONG THEM, ONE (B)(6)MALE PATIENT SUFFERED EPIDURAL HEMATOMA. PATIENT REQUIRED EXTENDED HOSPITAL STAY. SPINAL HEMATOMA WAS ENLARGED AND CAUSED PARAPLEGIA AS WELL AS RESPIRATORY PROBLEMS; PATIENT DECLINED FURTHER THERAPY AND DIED. NAVISTAR THERMOCOOL CATHETER WAS USED IN THIS EVENT. THE AUTHOR STATED THAT THE EVENT WAS NOT RELATED TO BWI DEVICE; THE EVENT WAS LED BY ANTICOAGULATION ONLY AND PATIENT CONDITION RELATED. TITLE: ¿CLINICAL BENEFIT OF ABLATING LOCALIZED SOURCES FOR HUMAN ATRIAL FIBRILLATION¿ THE PURPOSE OF THIS STUDY WAS TO ANALYZE THE ROLE OF ROTORS AND FOCAL SOURCES IN A LARGE ACADEMIC REGISTRY OF CONSECUTIVE PATIENTS UNDERGOING SOURCE MAPPING FOR AF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349644 NAVISTAR® THERMOCOOL® CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (IRWINDALE) D-1197-16-S UNKNOWN_D-1197-16-S IRW

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| H