BEUDAMED
    FDA Adverse Event Other Summary report: N

    VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER

    MDR report key: 577424 · Received February 16, 2005

    Report

    Report Number
    9673241-2005-00061
    Event Type
    Other
    Date Received
    February 16, 2005
    Date of Event
    January 17, 2005
    Report Date
    January 17, 2005
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LASSO CATHETER DISTAL SHELF WAS STUCK AND TRAPPED IN THE MITRAL VALVE DURING PROCEDURE. DR. HAD A HARD TIME PULLING IT OUT. EVENTUALLY IT WAS PULLED OUT WITHOUT ANY ADVERSE CONSEQUENCES TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER DIAGNOSTIC CATHETER DRF BIOSENSE WEBSTER D7-L10-15-RT 13003844

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO