BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRO 10 NEURO GUIDEWIRE

    MDR report key: 940616 · Received November 7, 2007

    Report

    Report Number
    6000078-2007-00290
    Event Type
    Injury
    Date Received
    November 7, 2007
    Date of Event
    July 1, 2007
    Report Date
    October 10, 2007
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510(K)#: K023700, K002907. PER THE DEVICE DIRECTIONS FOR USE (DFU): "BEFORE A GUIDE WIRE IS ADVANCED OR WITHDRAWN, VERIFY TIP MOVEMENT UNDER FLUOROSCOPY TO PREVENT THE POSSIBILITY OF VESSEL PERFORATION OR GUIDE WIRE DAMAGE." AS WELL, PER THE DFU: "WARNING: OBSERVE ALL GUIDE WIRE MOVEMENT IN THE VESSEL USING FLUOROSCOPY. DO NOT MOVE OR TORQUE A GUIDE WIRE WITHOUT OBSERVING CORRESPONDENT MOVEMENT OF THE DISTAL GUIDE WIRE TIP; OTHERWISE, GUIDE WIRE DAMAGE, SUCH AS TIP SEPARATION, AND/OR VESSEL TRAUMA MAY OCCUR. ALWAYS ADVANCE OR WITHDRAW THE GUIDE WIRE SLOWLY AND CAREFULLY."

    Description of Event or Problem · 1

    IT WAS REPORTED IN 2007, THAT DURING AN AVM (ARTERIOVENOUS MALFORMATION) EMBOLIZATION PROCEDURE, WITHDRAWAL OF THE SUBJECT DEVICE (GUIDEWIRE) INTO THE MICROCATHETER "... RESULTED IN SHEARING OF VESSEL WALL AND FRANK EXTRAVASATION OF CONTRAST FROM VESSEL ITSELF." THE SUBJECT DEVICE "...CAUGHT PART OF THE INTIMAL LAYER OF THE ARTERY AND BECAME STUCK. IT COULD NOT BE ADVANCED OR PULLED BACK. EVENTUALLY, THE WIRE ALONG WITH MICROCATHETER WERE REMOVED FROM THE PT..." THE ARTERY WAS RE-ACCESSED WITH ANOTHER SYSTEM. THE PERFORATED ACA (ANTERIOR COMMUNICATING ARTERY) BRANCH WAS SACRIFICED. THE PROCEDURE WAS COMPLETED AS THE AVM WAS "...SUCCESSFULLY TREATED." THE PT CONDITION RESULTING FROM THE PROCEDURE IS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO 10 NEURO GUIDEWIRE DQX - WIRE, GUIDE, CATHETER DQX NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP. 1631

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention MICROCATHETER (UNK MFG)