BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F/G ATLANTIS SR PRO2 - 39014

    MDR report key: 687343 · Received March 13, 2006

    Report

    Report Number
    6000084-2006-00008
    Event Type
    Injury
    Date Received
    March 13, 2006
    Date of Event
    March 3, 2006
    Report Date
    March 10, 2006
    Manufacturer
    SCIMED, A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE LESION WAS 99% STENOSIS WITH CALCIFICATION AND VERY TORTUOUS. A GUIDE WIRE WAS CHANGED BY USING A MICROCATHETER TO A RUNTHROUGH OR WHISPER MS AFTER A MICRACLE3 GUIDE WIRE MANAGED TO CROSS THE LESION. THEN, THE LESION WAS EXPANDED BY A VOYAGER 15/1.5 AND A QUANTUM MAVERICK 12/2.25 AFTER TJAT. A CU[JER 18/2.5 WAS ABLE TO CROSS THE LESION EVEN THOUGH RESISTANCE OCCURRED, AND IT WAS DEPLOYED AT 16 ATMS. THEN, THIS CATHETER WAS ADVANCED WITH IMAGING FOR CHECKING THE STENT. THE OUTER SHEATH WAS ADVANCED TILL STENT DISTAL. HOWEVER, THE TRANSDUCER WAS ABLE TO BE ADVANCED ABOUT STENT MIDDLE, BUT IT WASN'T ABLE TO BE ADVANCED TO MORE OVER BECAUSE OF INADEQUATE DILATATION OR VESSEL TORTUOUS. BECAUSE THE STENT DILATATION WASN'T ENOUGH, THE TRANSDUCER WAS PUSHED AS FAR AS POSSIBLE. THEN, WHEN THE CATHETER INTENDED TO BE PULLED OUT WITH IMAGING, RESISTANCE OCCURRED AND WITHDRAWAL WAS STOPPED. AND THE GUIDE WIRE TRIED TOBE REINSERTED BECAUSE IT CAME OFF, IT WASN'T ABLE TO BE INSERTED. THEN, THE TRANSDUCER WAS PULLED OUT AND THE GUIDE WIRE'S PROXIMAL SIDE WAS ADVANCED TO THIS LUMEN. BUT THIS CATHETER WASN'T ABLE TO BE MOVED. FINALLY, THE PATIENT WAS TRANSFERRED TO OTHER HOSPITAL FOR SURGICAL OPERATION. WHEN THE STENT WAS DEPLOYED AT A BALLOON AT TRANSFERRED HOSPITAL, THE CATHETER WAS ABLE TO BE PULLED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F/G ATLANTIS SR PRO2 - 39014 INTRAVASCULAR ULTRASOUND IMAGING CATHETER DQO SCIMED, A DIVISION OF BOSTON SCIENTIFIC CORP. 39014 8245592

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention