BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INQUIRY OPTIMA STEERABLE DIAGNOSTIC CATHETER

    MDR report key: 765732 · Received November 4, 2005

    Report

    Report Number
    2030404-2005-00002
    Event Type
    Malfunction
    Date Received
    November 4, 2005
    Date of Event
    October 7, 2005
    Report Date
    November 4, 2005
    Manufacturer
    IRVINE BIOMEDICAL, INC. (IBI)
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE FOR THE PROTRUSION OF THE NITINOL WIRE OUT FROM THE CATHETER BODY WAS DUE TO USER NOT FOLLOWING THE INSTRUCTIONS FOR USE (IFU) AND INCORRECTLY REMOVING THE CATHETER FROM THE INTRODUCER SHEATH WHILE THE CATHETER DISTAL LOOP WAS STILL IN A CLOSED (IE. UNRELAXED) POSITION. THIS PROCEDURE CONFLICTS WITH THE IFU WHICH STATES: "TO REMOVE THE CATHETER FROM INTRODUCTER SHEATH, MAKE SURE TO TURN THE ROTATING KNOB COUNTER CLOCKWISE FULLY AND PULL THE THUMB CONTROL DOWNWARD COMPLETELY TO MAKE THE LOOP LARGER AND STRAIGHTEN SHAFT OF CATHETER BEFORE REMOVAL FROM INTRODUCER."

    Description of Event or Problem · 1

    THE INQUIRY OPTIMA CATHETER WAS INSIDE OF AN INTRODUCTER SHEATH FOR MAPPING AND THE DOCTOR FELT THAT THE CATHETER BECAME DIFFICULT TO MOVE INSIDE OF THE INTRODUCER. THE CATHETER WAS REMOVED FROM THE PATIENT WITH NO INJURY TO THE PATIENT. UPON REMOVAL, THE INNER NITINOL WIRE OF THE CATHETER PROTRUDED OUT OF THE CATHETER BODY.

    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 35809

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN