BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO -14 NEURO GUIDEWIRE

    MDR report key: 793555 · Received November 30, 2006

    Report

    Report Number
    6000078-2006-00579
    Event Type
    Malfunction
    Date Received
    November 30, 2006
    Date of Event
    November 2, 2006
    Report Date
    November 2, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION
    Product Code
    DQX
    PMA / PMN Number
    k032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    G5. ALL MANUFACTURERS: PMA/510(K) #: K023700, K002907. THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER ON 11/27/2006 FOR EVALUTION. AN INVESTIGATION ON THE DEVICE IN QUESTION HAS BEEN INITIATED. BASED ON THE INFORMATION KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF FURTHER SIGNIFICANT INFORMATION BECOMS AVAILABLE, A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC (BSC) IN 2006 THAT A CUSTOMER HAD PROBLEMS WITH A GUIDEWIRE DURING INTRODUCTION. ACCORDING TO THE CUSTOMER: "CUSTOMER FELT A LOT OF FRICTION UPON INTRODUCING THE GUIDEWIRE (DEVICE IN QUESTION) THROUGH THE 3-WAY AND THE (BSC) CATHETER. CUSTOMER REMOVED THE GUIDEWIRE (DEVICE IN QUESTION) AND NOTICED WHAT HE BELIEVES IS SOME COATING THAT CAME OFF THE GUIDEWIRE (DEVICE IN QUESTION) AND CHOSE A DIFFERENT BSC GUIDEWIRE AND WAS ABLE TO SUCCESSFULLY COMPETE THE PROCEDURE." NO PATIENT COMPLICATIONS WERE REPORTED. THIS EVENT OCCURRED OUTSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO -14 NEURO GUIDEWIRE DQX: GUIDEWIRE DQX BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION 1302 B09119

    Patients

    Seq Age Sex Outcome Treatment
    1 *