BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F/G ATLANTIS SR PRO2

    MDR report key: 1020723 · Received March 26, 2008

    Report

    Report Number
    2939204-2008-00102
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQO
    PMA / PMN Number
    K063313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING DEPLOYMENT OF A STENT IN THE LEFT CIRCUMFLEX (LCX) ARTERY, THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED FOR CONFIRMATION OF THE LESION. THE IVUS CATHETER BECAME STUCK ON THE STENT EDGE DURING WITHDRAWAL. THE IMAGING CORE WAS REMOVED FROM THE OUTER SHEATH OF THE IVUS CATHETER AND A WIRE WAS INSERTED AND PUSHED. THE IVUS CATHETER WAS SUCCESSFULLY RETRIEVED FROM THE STENT EDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F/G ATLANTIS SR PRO2 CORONARY IMAGING CATHETER DQO BOSTON SCIENTIFIC CORP. 39014 11388282

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT: CYPHER 3.0 X 23