BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC 10-3D/3D-SHAPE SYNERG DETECTION CIRCUIT

    MDR report key: 837833 · Received February 20, 2007

    Report

    Report Number
    6000078-2007-00058
    Event Type
    Malfunction
    Date Received
    February 20, 2007
    Date of Event
    January 23, 2007
    Report Date
    January 23, 2007
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORTATION
    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

    ADDITIONAL PMA/510(K): K001083. BASED ON THE INFORMATION 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 IN 2007, THAT A CUSTOMER ENCOUNTERED PROBLEMS DURING USE OF A COIL IN AN EMBOLIZATION PROCEDURE. ACCORDING TO THE CUSTOMER: "IT GOT UNRAVELED WITH EASE AT REPOSITIONING INSIDE THE BODY. THEN, THE COIL WAS FRACTURED AT THE TIP OF THE DELIVERY WIRE." FURTHER CLARIFICATION ON THE EVENT DESCRIPTION: "THE COIL GOT EASILY DETACHED AT THE DETACHMENT ZONE. THIS EVENT OCCURRED IN THE DISTAL SHAFT OF THE MICRO CATHETER. THE COIL COULD BE REMOVED WITH THE MICRO CATHETER WITHOUT PROBLEM." THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT CONDITION WAS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 10-3D/3D-SHAPE SYNERG DETECTION CIRCUIT 84 HCG DETACHABLE COIL HCG NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORTATION 345103-4 6611693

    Patients

    Seq Age Sex Outcome Treatment
    1 * EXCELSIOR SL-10 MICROCATHETER