BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOSENSE WEBSTER LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER

    MDR report key: 2782927 · Received June 22, 2007

    Report

    Report Number
    2029046-2007-00076
    Event Type
    Other
    Date Received
    June 22, 2007
    Date of Event
    May 17, 2007
    Report Date
    June 22, 2007
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS FOR USE STATES ¿THE RETROGRADE APPROACH IS CONTRAINDICATED BECAUSE OF RISK OF ENTRAPPING THE LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER IN THE LEFT VENTRICLE OR VALVULAR APPARATUS. THE LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER IS NOT RECOMMENDED FOR USE IN THE VENTRICLES." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PULMONARY MAPPING PROCEDURE, THE CATHETER RING TIP WAS ENTRAPPED IN THE MITRAL VALVE CHORDAE TENDINAE. MEDICAL INTERVENTION ADMINISTERED WAS OPEN HEART SURGICAL INTERVENTION. THE CAUSALITY OF THE ADVERSE EVENT WAS DETERMINED TO BE PROCEDURE RELATED. THE PROGNOSIS OF THE PATIENT WAS REPORTED TO BE IN SATISFACTORY CONDITION AND FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER ELECTROPHYSIOLOGY CATHETER DRF BIOSENSE WEBSTER, INC. D-1237-02-S UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization