BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ STEER NAVIGATIONAL 4MM

    MDR report key: 5886896 · Received August 18, 2016

    Report

    Report Number
    2029046-2016-00099
    Event Type
    Death
    Date Received
    August 18, 2016
    Date of Event
    December 31, 2014
    Report Date
    July 28, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. OTHER COMPANY¿S DEVICES WERE USED DURING THIS STUDY: ENSITE VELOCITY (ST. JUDE MEDICAL), ABLATION CATHETER (ST. JUDE MEDICAL). (B)(6). EVALUATION, METHODS : NO TESTING METHODS PERFORMED. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: DEVICE DISCARDED BY USER, UNABLE TO FOLLOW-UP. (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 1 PATIENT FROM KNOWN HEART DISEASE (KDH) GROUP UNDERWENT RADIOFREQUENCY CATHETER ABLATION USING 4 MM IRRIGATED ABLATION CATHETER AND EXPIRED FROM AN ELECTRO-MECHANICAL DISSOCIATIVE (EMD) ARREST. THE DEATH OCCURRED > 30 DAYS AFTER AF ABLATION PROCEDURE. 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, THIS EVENT IS UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE UNDERLYING PATIENT'S CONDITION. TITLE: ¿THE IMPACT OF KNOWN HEART DISEASE ON LONG-TERM OUTCOMES OF CATHETER ABLATION IN PATIENTS WITH ATRIAL FIBRILLATION AND LEFT VENTRICULAR SYSTOLIC DYSFUNCTION: A MULTICENTER INTERNATIONAL STUDY¿ THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE IMPACT OF CARDIOMYOPATHY ETIOLOGY ON LONG-TERM OUTCOMES POST-CATHETER ABLATION. . THE STUDY WAS CONDUCTED FROM 2002-2014. SUSPECTED DEVICE IS 4 MM IRRIGATED CATHETER, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN. BWI TAKES CONSERVATIVE APPROACH TO OPEN THIS COMPLAINT UNDER ABLATION CATHETER EZ STEER NAVIGATIONAL 4MM IRRIGATED CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536883 EZ STEER NAVIGATIONAL 4MM SIMILAR DEVICE BN7TCDD4L, PMA # P990025/S12 DRF BIOSENSE WEBSTER, INC. (IRWINDALE) D-1268-00 UNK_EZ STEER NAVI 4MM (TC)

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death