BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F/G ATLANTIS SR PRO2

    MDR report key: 1071783 · Received July 7, 2008

    Report

    Report Number
    2939204-2008-00269
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 TARGET LESION WAS CALCIFIED WITH MODERATE TORTUROSITY. THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS UNABLE TO CROSS THE LESION. THE LESION WAS PRE-DILATED WITH A BALLOON. THEN TWO STENTS WERE PLACED, THE FIRST IN MID LAD AND THE SECOND IN THE PROXIMAL LAD. THE PHYSICIAN ATTEMPTED TO CROSS THE DEPLOYED STENTS, WITH THE IVUS BUT RESISTANCE WAS FELT. THE PHYSICIAN THOUGHT THAT THE IMAGING CATHETER MAY HAVE BEEN TRAPPED IN THE SECOND DEPLOYED STENT'S STRUT. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER, THE PROXIMAL EDGE OF THE STENT WAS STRETCHED. THE PHYSICIAN WAS ABLE TO REMOVE THE CATHETER AND THE PROCEDURE WAS COMPLETED, WITH NO PATIENT COMPLICATIONS.

    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 11457342

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 2.0-20MM - MANUFACTURER-UNK| DRIVER STENT| TSUNAMI STENT| SPEEDER BALLOON| 3.0-30MM (SECOND) - MANUFACTURER- UNK| 2.0-30MM (FIRST) - MANUFACTURER-TERUMO