BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER NAVISTAR DS RMT DIAGNOSTIC/ABLATION STEERABLE CATHETER

    MDR report key: 2971231 · Received September 7, 2007

    Report

    Report Number
    2029046-2007-00006
    Event Type
    Injury
    Date Received
    September 7, 2007
    Date of Event
    August 21, 2007
    Report Date
    September 7, 2007
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING AN AUDIT OF OUR COMPLAINTS, WE FOUND THIS COMPLAINT WHICH WAS INADVERTENTLY NOT SUBMITTED AS AN MDR. THIS MDR IS THE FIRST ONE TO BE SUBMITTED LATE IN THE LAST TWO YEARS. THE SECTION ON WARNINGS AND PRECAUTIONS IN THE INSTRUCTIONS FOR USE STATES "WHEN USING THE BLOSENSE WEBSTER NAVISTAR RMT DS DIAGNOSTIC/ABLATION STEERABLE CATHETER WITH THE CARTO RMT EP NAVIGATION SYSTEM, YOU SHOULD USE CAREFUL CATHETER WITH THE CARTO RMT EP NAVIGATION SYS, YOU SHOULD USE CAREFUL MANIPULATION IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER WHEN RESISTANCE IS ENCOUNTERED." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION CASE, THE 8MM NAVISTAR RMT CATHETER WAS USED WITH THE CARTO SYS TO CREATE MAPS AND THEN DELIVER RADIOFREQUENCY ENERGY. IT WAS THEN NOTICED THAT THE PT'S BLOOD PRESSURE HAD DECREASED. THE PT WAS REPORTEDLY TRANSFERRED TO THE OPERATING ROOM TO REPAIR THE CARDIAC PERFORATION. IT WAS FOUND THAT A 4MM PERFORATION WAS CREATED BETWEEN THE LEFT ATRIAL APPENDAGE AND THE ATRIOVENTRICULAR GROOVE DUE TO THE RADIOFREQUENCY APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER NAVISTAR DS RMT DIAGNOSTIC/ABLATION STEERABLE CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER, INC. NAVISTAR RMT UNK NAVISTA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening