BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F/G ATLANTIS SR PRO

    MDR report key: 1202995 · Received October 17, 2008

    Report

    Report Number
    2939204-2008-00478
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO CONFIRM THE DEPLOYMENT OF TWO STENT FOR A LESION IN THE LEFT ANTERIOR DESCENDING (LAD). THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER, BUT WAS UNSUCCESSFUL AS THE CATHETER GOT STUCK IN THE DISTAL PART OF THE SECOND STENT. IN ATTEMPT TO FREE THE CATHETER, THE PHYSICIAN REMOVED THE IMAGING CORE AND INTRODUCED A GUIDEWIRE. AT THIS POINT, THE IVUS CATHETER WAS FREED AND WITHDRAWN WITHOUT PT COMPLICATIONS. ANGIOGRAPHY WAS PERFORMED; THE DISTAL EDGE OF THE STENT WAS LIFTED UP, THE STENT WAS POST DILATED WITH A BALLOON AND PLACEMENT WAS "OKAY". REFER TO ASSOCIATED MFR REPORT NUMBER 2134265-2008-03067.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F/G ATLANTIS SR PRO CORONARY IMAGING CATHETER DQO BOSTON SCIENTIFIC CORP. H749390140 11853039

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 2ND- BSC LIBERTE STENT SYSTEM 2.75 MM| 1ST - BSC CYPHER STENT 3MM| GUIDEWIRE & GUIDE CATHETER - UNK MFR