BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC 18-SOFT SYNERG DETECTION CIRCUIT

    MDR report key: 879208 · Received September 13, 2006

    Report

    Report Number
    6000078-2006-00413
    Event Type
    Malfunction
    Date Received
    September 13, 2006
    Date of Event
    August 11, 2006
    Report Date
    August 17, 2006
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    HCG
    PMA / PMN Number
    K991134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION HAS BEEN RETURNED TO THE MANUFACTURER AND IS CURRENTLY IN PROCESS OF EVALUATION. BASED ON THE INFORMATION KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONFIRM THE USER'S COMPLAINT AND CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF FURTHER SIGNIFICANT INFORMATION IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW. ADD'L PMA/510 (K) # IS K001083.

    Description of Event or Problem · 1

    THE HOSP REPORTED AN INTERNAL CAROTID ARTERY PROCEDURE. THE HOSP REPORTED THAT WHEN THE OUTER BOX WAS OPENED AND THE POUCH WAS REMOVED FROM THE BOX, A LOT OF BLACK MATERIALS HAD ALREADY ATTACHED OUTSIDE THE POUCH. THE DEVICE IN QUESTION WAS USED IN THE PROCEDURE (COMPLETED PROCEDURE WITH DEVICE IN QUESTION). THE HOSP REPORTED THAT THERE WERE NO PT COMPLICATIONS AND THAT THE PT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 18-SOFT SYNERG DETECTION CIRCUIT DETACHABLE COIL HCG NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION 351308-4 0008337476

    Patients

    Seq Age Sex Outcome Treatment
    1 *