BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER LASSO CATHETER

    MDR report key: 1001053 · Received February 22, 2008

    Report

    Report Number
    2029046-2008-00004
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 23, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K002333
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS FOR USE STATES "THE RETROGRADE APPROACH IS CONTRAINDICATED BECAUSE OF RISK OF ENTRAPPING THE LASSO VARIABLE CIRCULAR MAPPING CATHETER IN THE LEFT VENTRICLE OR VALVULAR APPARATUS. THE LASSO VARIABLE MAPPING CATHETER IS NOT RECOMMENDED FOR USE IN THE VENTRICLES. EVAL SUMMARY: THE CUSTOMER INDICATED THAT THE LASSO WAS TRAPPED IN THE MITRAL VALVE. THE CATHETER WAS RECEIVED WITH A STRETCHED AND BROKEN LASSO LOOP WITH MISSING BALL TIP. THE PRODUCT WAS VISUALLY INSPECTED AND THE STRETCHED SPINE COVER INDICATES THAT AN EXCESSIVE FORCE WAS APPLIED. THE IFU STATES THAT THE RETROGRADE APPROACH IS CONTRAINDICATED BECAUSE OF RISK OF ENTRAPPING THE LASSO IN THE LEFT VENTRICLE OR VALVULAR APPARATUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LASSO CATHETER WAS ENTRAPPED IN THE MITRAL VALVE DURING THE PROCEDURE. OPEN HEART SURGERY WAS REQUIRED TO REMOVE THE CATHETER AND REPAIR THE MITRAL VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER LASSO CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (IRWINDALE) D-1220-38-S UNKNOWN_D-1220-

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Hospitalization| L| R