BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO -10 NEURO GUIDEWIRE

    MDR report key: 797795 · Received December 15, 2006

    Report

    Report Number
    6000078-2006-00636
    Event Type
    Malfunction
    Date Received
    December 15, 2006
    Date of Event
    November 24, 2006
    Report Date
    November 29, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV
    Product Code
    DQX
    PMA / PMN Number
    k032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE IN QUESTION HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. BASED ON THE INFORMATION KNOWN AT THIS TIME, BOSTON SCIENTIFIC HAS CONCLUDED THAT THE CAUSE OF THE USER'S EXPERIENCE WAS USER RELATED. THE DEVICE WAS USED AFTER ITS EXPIRATION DATE. ADD'L PMA/510(K): K023700, K002907.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC ON 11/29/2006 A PRODUCT PROBLEM ASSOCIATED WITH A CEREBRAL AVM (ARTERIOVENOUS MALFORMATION) EMBOLIZATION PROCEDURE. IT WAS REPORTED THAT "DURING PRE SHAPING OF THE WIRE'S (DEVICE IN QUESTION) TIP, THE TIP RUPTURED. THE (DEVICE IN QUESTION) WAS NEVER USED IN A PATIENT." IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS AND THAT THE PATIENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO -10 NEURO GUIDEWIRE DQX - GUIDEWIRE DQX BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV 1631 B04199

    Patients

    Seq Age Sex Outcome Treatment
    1 *