BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1950682 · Received December 29, 2010

    Report

    Report Number
    MW5018783
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    December 27, 2010
    Report Date
    December 29, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAULTY/DEFECTIVE GUIDING CATHETER WITH SIGNIFICANT HOLE OR CRACK IN THE HUB. DEFECT WAS DISCOVERED WHEN CLEARING THE CATHETER. PT DEVELOPED BRADYCARDIA FROM AN AIR EMBOLUS IN THE RIGHT CORONARY ARTERY. A NEW GUIDE WAS EXCHANGED AND AIR EMBOLUS WAS ASPIRATED WITH THE NEW CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC 6F MEDTRONIC GUIDING CATHETER JR 4.0 DQY MEDTRONIC 0005142331

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Disability