BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERIC - LASSO

    MDR report key: 6001622 · Received October 5, 2016

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    Report

    Report Number
    2029046-2016-00178
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    December 31, 2013
    Report Date
    September 12, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 PRODUCT USED IN THIS STUDY: CARTO MAPPING SYSTEM. (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE 471 PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION UNDERWENT PVI FOR THE FIRST TIME. OF THESE, 23 SUFFERED MAJOR COMPLICATIONS, WHICH WERE REPRESENTED BY A BAR GRAPH, THEREFORE ESTIMATED. OF THE 23 COMPLICATIONS, APPROXIMATELY 12 PATIENTS SUFFERED CARDIAC TAMPONADE. THERE IS NO INFORMATION REGARDING INTERVENTIONS. THE REMAINDER OF THE COMPLICATIONS CITED IN THIS ARTICLE WILL BE REPORTED SEPARATELY. 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. TITLE: ¿WHO IS THE OPERATOR, THAT IS THE QUESTION: A MULTICENTRE STUDY OF CATHETER ABLATION OF ATRIAL FIBRILLATION". THE PURPOSE OF THIS STUDY WAS TO TEST WHETHER THE PROCEDURE VOLUME OF EACH OPERATOR WAS ASSOCIATED WITH THE OUTCOME OF AF ABLATION IN HIGH-VOLUME CENTRES. THE 471 PATIENTS WITH PAROXYSMAL AF UNDERWENT PULMONARY VEIN (PV) ISOLATION FOR THE FIRST TIME. THE STUDY WAS CONDUCTED FROM JANUARY 2012 TO DECEMBER 2013. SUSPECT DEVICE IS A LASSO MAPPING CATHETER, HOWEVER CATALOG AND LOT NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651410 GENERIC - LASSO GENERIC - LASSO LPB BIOSENSE WEBSTER, INC. (IRWINDALE) D-1220-00 UNKNOWN_LASSO

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R