BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO 2/14 SOFT

    MDR report key: 1193456 · Received October 8, 2008

    Report

    Report Number
    2939204-2008-00450
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 11, 2008
    Manufacturer
    NEUROVASCULAR DIV, BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    PMA / PMN Number
    K053268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN USED THE DOUBLE WIRE TECHNIQUE TO GAIN ACCESS ACROSS A VERY LARGE FUSIFORM ANEURYSM LOCATED IN THE VERTEBRAL/BASILAR REGION OF THE BRAIN. PT'S ANATOMY PRESENTED CHALLENGES SINCE THE PATH WAS VERY TORTUOUS. TWO GUIDEWIRES WERE SUCCESSFULLY PLACED PROXIMALLY INTO BOTH POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) AND BASILAR ARTERY (BA). ON REMOVING BOTH GUIDEWIRES, IT WAS NOTED THAT THE PROXIMAL COATING ON ONE OF THE GUIDEWIRE WAS FLAKING OFF. IT WAS CONFIRMED THAT THERE WERE NO PARTICLES FLAKED OFF INSIDE THE PT'S BODY. THE ANEURYSM STENTING PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO REPORTED COMPLICATIONS DUE TO THIS EVENT AND THE PT WAS IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO 2/14 SOFT (DQX) NEURO GUIDEWIRE DQX NEUROVASCULAR DIV, BOSTON SCIENTIFIC CORP. 2601 B14161

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR BALT STEEL WIRE| VASCO MICROCATHETER| SYNCHRO WIRE| LEO STENT| BALT SHEATH