BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INQUIRY OPTIMA STEERABLE DIAGNOSTIC CATHETER

    MDR report key: 669385 · Received January 23, 2006

    Report

    Report Number
    2030404-2006-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2006
    Date of Event
    December 16, 2005
    Report Date
    January 23, 2006
    Manufacturer
    IRVINE BIOMEDICAL, INC. (IBI)
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A WIRE WAS SEEN PROTRUDING OUT OF THE BODY OF THE CATHETER JUST BELOW THE BAND ELECTRODES. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INQUIRY OPTIMA STEERABLE DIAGNOSTIC CATHETER ELECTROPHYSIOLOGY CATHETER DRF IRVINE BIOMEDICAL, INC. (IBI) 81687 34497

    Patients

    Seq Age Sex Outcome Treatment
    1 *