BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERGREEN PTCA CATHETER

    MDR report key: 55051 · Received September 21, 1996

    Report

    Report Number
    2083093-1996-00005
    Event Type
    Malfunction
    Date Received
    September 21, 1996
    Date of Event
    August 1, 1996
    Report Date
    September 19, 1996
    Manufacturer
    MEDTRONIC INTERVENTIONAL VASCULAR, INC.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ANGIOPLASTY CATHETER WAS PLACED IN TARGET LESION, INFLATED AND REPORTEDLY BURST AT 6 ATM WHICH WAS BELOW RATED ATM OF 8. THE CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PT COMPLICATIONS. NO OTHER DETAILS OF THE INCIDENT WERE RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVERGREEN PTCA CATHETER CORONARY ANGIOPLASTY BALLOON CATHETER LOX MEDTRONIC INTERVENTIONAL VASCULAR, INC. EM4025 51103C2

    Patients

    Seq Age Sex Outcome Treatment
    1 *