BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS SR PRO

    MDR report key: 1364505 · Received April 15, 2009

    Report

    Report Number
    2939204-2009-00352
    Event Type
    Injury
    Date Received
    April 15, 2009
    Date of Event
    September 18, 2008
    Report Date
    March 17, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    DQO
    PMA / PMN Number
    K063313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A DRUG CLINICAL STUDY, AN INTRAVASCULAR ULTRASOUND (IVUS) WAS BEING USED TO IMAGE A MARGINAL LESION (AS SEEN BY ANGIOGRAPHY) IN THE RCA. THE PT EXPERIENCED PERIPROCEDURAL ACUTE CORONARY SYNDROME: CARDIAC CHEST PAIN WITH TRANSIENT ST SEGMENT ELEVATION, MINIMAL TROPONIN I INCREASE (0.3UG/L). THE IVUS PROCEDURE WAS STOPPED AND THE SYMPTOMS QUICKLY WITHDREW. NO REFLOW WAS OBSERVED ON THE ANGIOGRAPHY. REO-PRO BOLUS PLUS INFUSION WAS GIVEN, NORMAL TIMI III FLOW WAS OBSERVED. PT WAS TRANSFERRED TO THE WARD WITH NO PAIN AND NO ECG CHANGES OBSERVED ON THE MONITOR. THE PHYSICIAN DOES NOT RELATE THE ATLANTIS CATHETER AS BEING THE SOURCE OF THE CHEST PAIN. THE PHYSICIAN SPECULATED THROMBUS FORMATION ON THE CATHETER BECAUSE NO REFLOW WAS SEEN ON THE ANGIOGRAPHY AFTER WITHDRAWAL OF THE IVUS CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS SR PRO CORONARY IMAGING CATHETER DQO BOSTON SCIENTIFIC CORP H749389420 11702781

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other GUIDEWIRE: HI TORQUE WHISPER MS 0.014" 190CM| GUIDE CATHETER: MEDTRONIC LAUNCHER