BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOSENSE WEBSTER 7FR 10-POLE CIRCULAR MAPPING CATHETER

    MDR report key: 902606 · Received August 22, 2007

    Report

    Report Number
    2029046-2007-00098
    Event Type
    Other
    Date Received
    August 22, 2007
    Report Date
    August 20, 2007
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NO INFORMATION

    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.

    Description of Event or Problem · 1

    FROM HEART RHYTHM VOL 1, NO 5, NOVEMBER 2004, PAGES 558-561. ACCORDING TO THE ARTICLE, A BIOSENSE WEBSTER 7FR 10-POLE CIRCULAR MAPPING CATHETER BECAME ENTRAPPED IN THE MITRAL VALVE APPARATUS IN TWO PATIENTS AND IN THE PV IN ONE PATIENT. A SERIES MANEUVERS, WHICH INCLUDED USE OF ANOTHER CATHETER AND GUIDING SHEATHS AS WELL AS PUSHING FORWARD RATHER THAN PULLING BACK ON THE ENTRAPPED CATHETER, ALLOWED SAFE AND SUCCESSFUL RELEASE OF THE ENTRAPPED CATHETER IN ALL PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER 7FR 10-POLE CIRCULAR MAPPING CATHETER ELECTROPHYSIOLOGY CATHETER DRF BIOSENSE WEBSTER, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Life Threatening| R