BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERGREEN PTCA CATHETER

    MDR report key: 117920 · Received September 4, 1997

    Report

    Report Number
    2083093-1997-00037
    Event Type
    Injury
    Date Received
    September 4, 1997
    Date of Event
    July 28, 1997
    Report Date
    August 18, 1997
    Manufacturer
    MEDTRONIC INTERVENTIONAL VASCULAR, INC.
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A J&J STENT WAS LOADED ONTO THE BALLOON CATHETER. DURING THE ATTEMPT TO IMPLANT THE STENT IN AN ANGULAR LESION A DISSECTION WAS OBSERVED. THE PT WAS SENT TO CABG SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVERGREEN PTCA CATHETER CORONARY BALLOON ANGIOPLASTY CATHETER LOX MEDTRONIC INTERVENTIONAL VASCULAR, INC. EM2035 70117D2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention J&J STENT