BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO-14 NEURO GUIDEWIRE

    MDR report key: 800837 · Received December 19, 2006

    Report

    Report Number
    6000078-2006-00640
    Event Type
    Malfunction
    Date Received
    December 19, 2006
    Date of Event
    November 30, 2006
    Report Date
    November 30, 2006
    Manufacturer
    NEUROVASCULAR , A DIV. OF BOSTON SCIENTIFIC CORP
    Product Code
    DQX
    PMA / PMN Number
    k032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510 (K) #: K023700, K002907. TO DATE, THE DEVICE IN QUESTION HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. BASED ON THE INFO KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC ON 11/30/2006 A PRODUCT PROBLEM ASSOCIATED WITH A MIDDLE CEREBRAL ARTERY ANEURYSM. IT WAS REPORTED THAT THE "CATHETER WAS DEPLOYED TO MC ANEURYSM, BUT PHYSICIAN FELT SOMETHING WRONG AND WITHDREW IT. THEN HE NOTICED THAT THE HYDROPHILIC COATING ON THE (DEVICE IN QUESTION) WAS PEELED OFF." IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE, THAT THERE WERE NO PATIENT COMPLICATIONS, AND THAT THE PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO-14 NEURO GUIDEWIRE DQX - GUIDEWIRE DQX NEUROVASCULAR , A DIV. OF BOSTON SCIENTIFIC CORP 1301 B09063

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR CATHETER (UNK MANUFACTURER)| THERAPY DATE.