BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INQUIRY AFOCUS II DIAGNOSTIC CATHETER

    MDR report key: 700759 · Received April 14, 2006

    Report

    Report Number
    2030404-2006-00006
    Event Type
    Malfunction
    Date Received
    April 14, 2006
    Date of Event
    March 16, 2006
    Report Date
    April 10, 2006
    Manufacturer
    IRVINE BIOMEDICAL, INC.(IBI)
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "AFTER TAKING OUT THE CATHETER, THE DOCTOR NOTICED PARTICLES OF ISOLATION ON THE TRANSITION BETWEEN THE SHAFT AND THE SPIRAL. IT IS UNCERTAINIF THERE ARE PARTICLES IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INQUIRY AFOCUS II DIAGNOSTIC CATHETER ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER DQO IRVINE BIOMEDICAL, INC.(IBI) 81595 37059

    Patients

    Seq Age Sex Outcome Treatment
    1 *