BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INQUIRY OPTIMA STEERABLE DIAGNOSTIC CATHETER

    MDR report key: 677515 · Received February 13, 2006

    Report

    Report Number
    2030404-2006-00003
    Event Type
    Malfunction
    Date Received
    February 13, 2006
    Report Date
    February 13, 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 CAME OUT OF THE BODY OF THE CATHETER BELOW THE CURVE. 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 34628

    Patients

    Seq Age Sex Outcome Treatment
    1 *