BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLAZER II

    MDR report key: 1620646 · Received March 3, 2010

    Report

    Report Number
    3001236349-2010-00009
    Event Type
    Death
    Date Received
    March 3, 2010
    Report Date
    February 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    LPB
    PMA / PMN Number
    P920047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE CODE ENTERED BECAUSE IT IS UNKNOWN IF THERE WAS ANY MALFUNCTION OF THE DEVICE. PER THE EVENT DESCRIPTION, SALES REPRESENTATIVE REPORTED THAT THERE WAS A POSSIBILITY THAT A BLAZER CATHETER WAS USED DURING AN ATRIAL FIBRILLATION CASE. THE PATIENT DIED FOUR DAYS AFTER THE PROCEDURE. UPON FURTHER FOLLOW-UP, IT WAS REPORTED THAT SALES REPRESENTATIVE HEARD ABOUT THE PATIENT DEATH WITH NO ADDITIONAL INFORMATION REGARDING THE CAUSE. ADDITIONALLY, IT IS UNKNOWN IF ANY BSC PRODUCTS WERE EVEN INVOLVED IN THE PROCEDURE. NO DETAILED INFORMATION WAS AVAILABLE FROM THE ACCOUNT REGARDING THE EVENT OR PATIENT. WE WERE UNABLE TO VERIFY ANY DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIPTION AS NO DEVICE WAS RETURNED FOR ANALYSIS. PER BLAZER II DIRECTION FOR USE, DEATH IS LISTED AS AN ADVERSE EFFECT THAT MAY BE ASSOCIATED WITH CARDIAC CATHETERIZATION AND ABLATION. THE POTENTIAL ROOT CAUSES AND POTENTIAL FAILURE MODES FOR DEVICE MALFUNCTION WERE REVIEWED IN BLAZER PROCESS FAILURE MODE AND EFFECT ANALYSIS. THE RESULT OF THIS REVIEW INDICATED THAT THE CURRENT MANUFACTURING PROCESS CONTROLS TO PREVENT THE FAILURES FROM OCCURRING ARE ADEQUATE. SINCE THE BATCH NUMBER IS UNKNOWN, THE MANUFACTURING RECORDS OF THE LAST 3 BATCHES SHIPPED TO THE CUSTOMER WITHIN SIX MONTHS PRIOR TO THE EVENT DATE WERE REVIEWED. THE REVIEW INDICATED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED IN ACCORDANCE WITH SPECIFICATIONS. SIMILAR COMPLAINT TREND WAS REVIEWED FOR THIS PRODUCT FAMILY, AND NO ADVERSE TRENDS WERE IDENTIFIED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    SALES REPRESENTATIVE REPORTED "POSSIBILITY THAT A BLAZER 8F 8MM WAS USED IN AN A-FIB ABLATION. 4 DAYS LATER THE PATIENT EXPIRED." ADDITIONAL INFORMATION RECEIVED ON 21 FEB 2010. "THE ACCOUNT IS UNABLE TO PROVIDE FURTHER INFORMATION REGARDING THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER II CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BOSTON SCIENTIFIC - SAN JOSE UNK45 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death