BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC 10-2D/2-DIAMETER SYNERG DETECTION CIRCUIT

    MDR report key: 835713 · Received April 4, 2007

    Report

    Report Number
    6000078-2007-00103
    Event Type
    Injury
    Date Received
    April 4, 2007
    Date of Event
    March 2, 2007
    Report Date
    March 8, 2007
    Manufacturer
    NEUROVASCULAR, DIV. OF BOSTON SCIENTIFIC CORP
    Product Code
    HCG
    PMA / PMN Number
    k991134
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 501K # K001083.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC ON 03/08/2007 THAT THERE WERE DETACHMENT PROBLEMS WITH GDC COILS UP TO THREE TIMES. THE POWER SUPPLY HAD INDICATED DETACHMENT AND THE VOLTAGE HAD BEEN UP TO 11. HOWEVER, THE COIL HAD NOT BEEN DETACHED. IN ONE CASE, THE COIL CAME OUT OF THE ANEURYSM SACK AND WAS RETRIEVED WITH A SNARE. IT WAS REPORTED THAT "ALL WENT WELL" AND THERE WAS NO RISK TO THE PATIENT AND NO PATIENT COMPLICATIONS. THE PATIENT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 10-2D/2-DIAMETER SYNERG DETECTION CIRCUIT 84 HCG-DETACHABLE COIL HCG NEUROVASCULAR, DIV. OF BOSTON SCIENTIFIC CORP 342410-4 8351136

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention POWER SUPPLY (BSC)| 35 COILS (UNKNOWN MFR)