BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATLANTIS SR PLUS

    MDR report key: 501551 · Received December 3, 2003

    Report

    Report Number
    501551
    Event Type
    Other
    Date Received
    December 3, 2003
    Date of Event
    July 1, 2003
    Report Date
    October 1, 2003
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CARDIAC CATHETERIZATION COMPLICATED BY THE IVUS CATHETER BECOMING SNAGGED IN THE DISTAL RIGHT CORONARY ARTERY AND WAS ONLY ABLE TO BE WITHDRAWN AFTER MULTIPLE ATTEMPTS AND MUCH MANIUPULATION BY SECOND DOCTOR CALLED IN TO ASSIST. THE PROCEDURE TOOK HOURS EXTRA TIME DUE TO GUIDEWIRE BECOMING KINKED. SUBSEQUENTLY, UPON POST STENT DILATION OF THE 2 CYPHER STENT, POOR REFLOW TO NO REFLOW OCCURRED DUE LIKELY TO THE DISTAL THROMBOEMBOLIZATION. AFTER COPIOUS AMOUNTS OF VARIOUS MEDICATIONS, REFLOW WAS RESTABLISHED. PATIENT HAD POSTPROCEDURE CHEST SORENESS AND RULED IN FOR A SMALL AMOUNT OF ST ELEVATION MYOCARDIAL INFARCTION WITH PEAK TROPONIN 1 OF 9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS SR PLUS IVUS CATHETER ITX BOSTON SCIENTIFIC CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other