BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR OTW

    MDR report key: 1031606 · Received April 17, 2008

    Report

    Report Number
    MW5006294
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 17, 2008
    Manufacturer
    MEDTRONIC INC
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE INFLATING THE BALLOON ON THIS DEVICE, WE HAD DIFFICULTY REACHING THE DESIRED ATMOSPHERE. THE PT IMMEDIATELY BECAME HYPOTENSIVE AND COMPLAINED OF PAIN WITH EKG CHANGES. THE NEXT IMMEDIATE INJECTION SHOWED NO FLOW TO THE CIRCUMFLEX AND DIAGONAL BRANCHES. AFTER THE PT WAS STABILIZED, THE DEVICE WAS REMOVED AND EXAMINED. THERE APPEARED TO BE A SMALL HOLE PROXIMAL TO THE BALLOON ON THE SHAFT OF THE CATHETER WITHIN THE BALLOON PORT. WE ASSUME THAT THIS ALLOWED AIR TO ENTER THE CORONARY SYSTEM DURING INFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR OTW ENDEAVOR NIQ MEDTRONIC INC 3.0MM X 9MM 0000618274

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening