BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INQUIRY OPTIMA STEERABLE DIAGNOSTIC CATHETER

    MDR report key: 669405 · Received January 27, 2006

    Report

    Report Number
    2030404-2006-00002
    Event Type
    Malfunction
    Date Received
    January 27, 2006
    Date of Event
    December 27, 2005
    Report Date
    January 27, 2006
    Manufacturer
    IRVINE BIOMEDICAL, INC. (IBI)
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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) 81683 35775

    Patients

    Seq Age Sex Outcome Treatment
    1 *