BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 654664 · Received August 29, 2005

    Report

    Report Number
    75940-2005-00001
    Event Type
    Malfunction
    Date Received
    August 29, 2005
    Date of Event
    June 6, 2005
    Report Date
    August 29, 2005
    Manufacturer
    ALLIANCE MEDICAL CORPORATION
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE LASSO CATHETER BROKE OFF DURING REMOVAL OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER LASSO ELECTROPHYSIOLOGY CATHETER DRF ALLIANCE MEDICAL CORPORATION UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR