BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC-18 2D COIL

    MDR report key: 1202406 · Received October 16, 2008

    Report

    Report Number
    2939204-2008-00476
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 27, 2008
    Report Date
    September 27, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    PMA / PMN Number
    K031049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DURAL ARTERIOVENOUS FISTULA EMBOLIZATION, THE PHYSICIAN SUCCESSFULLY DELIVERED TWELVE COILS WITHOUT ANY ISSUES. HOWEVER, THE THIRTEENTH COIL PREMATURELY DETACHED WITH APPROX 3CM OF THE PROXIMAL PART OF THE COIL REMAINING IN THE CATHETER. IT WAS CONFIRMED THAT THE EVENT HAPPENED WITHOUT ANY MANIPULATION DURING REPOSITIONING. THE FOLLOWING COIL PUSHED OUT THE REMAINING PORTION OF THE SUBJECT COIL INTO THE ANEURYSM. BOTH COILS WERE PROPERLY DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO REPORTED COMPLICATIONS DUE TO THIS EVENT. THERE WERE NO REPORTED COMPLICATIONS DUE TO THIS EVENT AND THE PT WAS IN A GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC-18 2D COIL (HCG) DETACHABLE COIL HCG NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. 352163-4 9611882

    Patients

    Seq Age Sex Outcome Treatment
    1 BOSTON SCIENTIFIC EXCELSIOR 1018 - SHAPED 45| SILVERSPEED 14 GUIDEWIRE: (MFR UNK)| 34 COILS: (MODEL & MFR UNK)| ENVOY 6F: GUIDE CATHETER