BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F/G ATLANTIS SR PRO SQUARE

    MDR report key: 1024221 · Received March 27, 2008

    Report

    Report Number
    2939204-2008-00110
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) PROXIMAL. THE LESION WAS 10% STENOSED WITH MODERATE TORTUOUS AND CALCIFICATION. THE INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO IMAGE THE LESION POST STENT PLACEMENT. WHEN THE PHYSICIAN WITHDREW THE CATHETER FROM THE LESION, IT CAUGHT IN THE STENT DISTAL EDGE. THE PHYSICIAN WITHDREW THE GUIDEWIRE. HE THEN WITHDREW THE CATHETER, WHICH ALLOWED THE CATHETER TO RELEASE THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F/G ATLANTIS SR PRO SQUARE CORONARY IMAGING CATHETER DQO BOSTON SCIENTIFIC CORPORATION 39014 11413964

    Patients

    Seq Age Sex Outcome Treatment
    1 CYPHER STENT, (SIZE UNKNOWN)| GUIDEWIRE, RUNTHROUGH