BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INQUIRY OPTIMA STEERABLE DIAGNOSTIC CATHETER

    MDR report key: 705058 · Received November 23, 2005

    Report

    Report Number
    2030404-2005-00004
    Event Type
    Malfunction
    Date Received
    November 23, 2005
    Date of Event
    October 25, 2005
    Report Date
    November 23, 2005
    Manufacturer
    IRVINE BIOMEDICAL, INC. (IBI)
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UPON REMOVING THE INQUIRY OPTIMA CATHETER FROM THE PATIENT, THE PHYISCIAN OBSERVED A WIRE COMING OUT OF THE DISTAL SHAFT OF THE CATHETER. PAIENT WAS UNHARMED BY ANY EVENT DURING THE PROCEDURE.

    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 35405

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN