BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITESEER-4F JR 4.0 100CM DX CATHETER

    MDR report key: 1032223 · Received April 18, 2008

    Report

    Report Number
    1220452-2008-00027
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 31, 2008
    Report Date
    March 31, 2008
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DQO
    PMA / PMN Number
    K984627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS INDICATED THAT THE SUBJECT DEVICE WILL NOT BE RETURNED FOR EVAL. THEREFORE, AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE CANNOT BE PERFORMED. THE LOT NUMBER FOR THE DEVICE IS KNOWN AND A REVIEW OF THE DEVICE HISTORY RECORD WILL BE CONDUCTED. DEVICE DISCARDED - NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT DURING THE DIAGNOSTIC PROCEDURE, THERE WAS BLOOD CLOT FORMATION INSIDE THE DIAGNOSTIC CATHETER. AN ATTEMPT TO OBTAIN ADDITIONAL INFO HAS BEEN MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITESEER-4F JR 4.0 100CM DX CATHETER DQO MEDTRONIC INC. NA 20030836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA