BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC 18 - 3D/3D-SHAPE SYNERG DETECTION CIRCUIT

    MDR report key: 810269 · Received August 3, 2006

    Report

    Report Number
    6000078-2006-00362
    Event Type
    Malfunction
    Date Received
    August 3, 2006
    Date of Event
    July 20, 2006
    Report Date
    July 21, 2006
    Manufacturer
    NEUROVASCUARL, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    HCG
    PMA / PMN Number
    K991134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA INFORMATION K001083. THE DEVICE IN QUESTION HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR EVALUATION. BASED ON THE INFORMATION KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCED. IF FURTHER SIGNIFICANT INFORMATION IS FOUND, OR IF THE DEVICE IN QUESTION IS RETURNED, A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A COILING PROCEDURE IN THE PERIPHERAL VASCULAR SYSTEM. THE HOSPITAL REPORTED THAT THE DEVICE IN QUESTION (COIL) FRACTURED WHILE IN THE CATHETER. THE PROWLER PLUS CATHETER AND DEVICE IN QUESTION, WILL BOTH BE SENT BACK TO THE BOSTON SCIENTIFIC. THE HOSPITAL REPORTED THAT THERE WERE NO PATIENT COMPLICATIONS, THAT THE PATIENT CONDITION IS FINE, AND THAT THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 18 - 3D/3D-SHAPE SYNERG DETECTION CIRCUIT DETACHABLE COIL HCG NEUROVASCUARL, A DIVISION OF BOSTON SCIENTIFIC CORPORATION 355123-4 6959014

    Patients

    Seq Age Sex Outcome Treatment
    1 * DETACHABLE COIL POWER SUPPLY| AND THE PROWLER PLUS CATHETER| GDC-18 3D 14MM X 30 CM