BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC 18-SOFT SYNERG DETECTION CIRCUIT

    MDR report key: 977889 · Received January 10, 2008

    Report

    Report Number
    2939204-2008-00006
    Event Type
    Injury
    Date Received
    January 10, 2008
    Date of Event
    December 8, 2007
    Report Date
    December 11, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    PMA / PMN Number
    K991134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL K 001083. THE ROOT CAUSE FOR THIS COMPLAINT CANNOT BE DETERMINED DEFINITIVELY. THE RISK OF STRETCHING WHILE MANEUVERING A DETACHABLE COIL IS NOTED IN THE DFU (DIRECTIONS FOR USE) FOR THE DEVICE IN QUESTION: "DUE TO THE DELICATE NATURE OF THE GDC COILS, ...., A COIL MAY OCCASIONALLY STRETCH WHILE BEING MANEUVERED. STRETCHING IS A PRECURSOR TO POTENTIAL MALFUNCTIONS, SUCH AS COIL BREAKAGE." A POSSIBLE CONTRIBUTORY FACTOR TO COIL BREAKAGE MAY BE DUE TO REPOSITIONING OF THE COIL. THE FOLLOWING IS STATED AS A PRECAUTION IN THE DFU: "IF COIL REPOSITIONING IS NECESSARY, TAKE SPECIAL CARE TO RETRACT COIL UNDER FLUOROSCOPY IN A ONE-TO-ONE MOTION WITH THE DELIVERY WIRE. IF THE COIL DOES NOT MOVE WITH A ONE-TO-ONE MOTION, OR REPOSITIONING IS DIFFICULT, THE COIL HAS BEEN STRETCHED AND COULD POSSIBLY BREAK."

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER THAT A CUSTOMER ENCOUNTERED DIFFICULTIES DURING USE OF A DETACHABLE COIL. ACCORDING TO THE CUSTOMER: THEY ADVANCED THROUGH A PROGRADE NEURO CATHETER AND THE COIL [DEVICE IN QUESTION] WAS REPOSITIONED SEVERAL TIMES; THE COIL BECAME STRETCHED AND THEN BROKE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE COIL PIECES USING A GOOSE NECK SNARE, AND ANOTHER COIL WAS SUCCESSFULLY PLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PT'S POST PROCEDURE CONDITION STATUS WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 18-SOFT SYNERG DETECTION CIRCUIT HCG: NEUROVASCULAR EMBOLIZATION COIL HCG BOSTON SCIENTIFIC CORP. 351512-4 9569548

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention