BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHRO - 14 NEURO GUIDEWIRE

    MDR report key: 925915 · Received October 9, 2007

    Report

    Report Number
    6000078-2007-00235
    Event Type
    Death
    Date Received
    October 9, 2007
    Date of Event
    August 17, 2007
    Report Date
    September 13, 2007
    Manufacturer
    BOSTON SCIENTIFIC NEUROVASCULAR DIVISION
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH: UNK AS THE PHYSICIAN HAD ONLY REPORTED, THE PT EXPIRED ONE WEEK FOLLOWING THE PROCEDURE, THE EXACT DATE OF DEATH WAS NOT DISCLOSED TO BOSTON SCIENTIFIC. ADDITIONAL PMA/510 (K): K023700, K002907.THE DEVICE IN QUESTION WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR TECHNICAL ANALYSIS AS IT WAS DISCARDED BY THE HOSPITAL. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. ADD'L INFO WAS REQUESTED FROM THE PHYSICIAN AND IT WAS REPORTED THE LEFT ANTERIOR CEREBRAL ARTERY (ACA) THE PHYSICIAN WAS ATTEMPTING TO ACCESS WAS VERY NARROW. THE PHYSICIAN APPLIED PRESSURE TO TRY AND MANIPULATE THE GUIDEWIRE THROUGH THE ACA UPON BECOMING STUCK. THE BLEED WAS NOT LOCATED IN THE SAME AREA AS THE ANEURYSM. IT IS UNK IF ANY DAMAGES, EITHER TO THE MICROCATHETER OR THE GUIDEWIRE, WERE NOTED UPON REMOVAL FROM THE PT FOLLOWING THIS REPORTED EVENT. THE CAUSE OF THE EVENT REMAINS UNK. HOWEVER, IT SHOULD BE NOTED THAT DIRECTIONS FOR USE (DFU) FOR THIS PRODUCT FAMILY UNDER THE WARNINGS SECTION STATE "NEVER ADVANCE OR WITHDRAW AN INTRAVASCULAR DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE IS DETERMINED BY FLUOROSCOPY. EXCESSIVE FORCE AGAINST RESISTANCE MAY RESULT IN SEPARATION OF THE GUIDEWIRE TIP, DAMAGE TO THE CATHETER, OR VESSEL PERFORATION".

    Description of Event or Problem · 1

    IN AN ATTEMPT TO ADVANCE THE MICROCATHETER OVER THE GUIDEWIRE TO THE ANEURYSM, THE GUIDEWIRE BECAME STUCK IN THE LEFT ANTERIOR CEREBRAL ARTERY (ACA). AN ATTEMPT TO MANIPULATE THE GUIDEWIRE FAILED. THE GUIDEWIRE AND THE MICROCATHETER WERE REMOVED FROM THE VASCULATURE. ANGIOGRAPHY WAS PERFORMED. BLEEDING WAS NOTED AT THE LEFT ICA BIFURCATION. HEPARIN REVERSAL FAILED TO STOP THE BLEEDING. THE PROCEDURE WAS CANCELED. THE PT WAS IN THE INTENSIVE CARE UNIT (ICU) IN A VEGETATIVE (COMATOSE) STATE AND EXPIRED ONE WEEK POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO - 14 NEURO GUIDEWIRE (DQX) NEUROVASCULAR GUIDEWIRE DQX BOSTON SCIENTIFIC NEUROVASCULAR DIVISION 1301 B10782

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death 6FR ENVOY CATHETER