BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC 10-SOFT 2D SR/2-DIAMETER

    MDR report key: 793351 · Received December 6, 2006

    Report

    Report Number
    6000078-2006-00586
    Event Type
    Injury
    Date Received
    December 6, 2006
    Date of Event
    November 9, 2006
    Report Date
    November 10, 2006
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    HCG
    PMA / PMN Number
    K991134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/ 510 (K) #: K001083. THE DEVICE IN QUESTION WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION BECAUSE IT WAS DISPOSED OF BY THE USER FACILITY. BASED ON THE INFORMATION KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC IN 11/2006 A PRODUCT PROBLEM REQUIRING INTERVENTION ASSOCIATED WITH AN EMBOLIZATION PROCEDURE OF THE BRAIN. IT WAS REPORTED THAT "IT WAS FELT THE RESISTANCE AT INSERTING THE FOURTH COIL (DEVICE IN QUESTION). THEREFORE, THIS UNIT WAS TRIED TO REMOVE AND THE (DEVICE IN QUESTION) GOT UNRAVELED. THOUGH IT WAS TRIED TO REMOVE WITH THE (MICROCATHETER), IT WAS FAILED. THE (DEVICE IN QUESTION) WAS ABLE TO BE REMOVED WITH THE (RETRIEVAL DEVICE). IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE; THAT THERE WERE NO PATIENT COMPLICATIONS; AND THAT THE PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 10-SOFT 2D SR/2-DIAMETER 84 HCG - DETACHABLE COIL HCG NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION 344715-SR4 8129334

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention EXCELSIOR 1018 MICROCATHETER| THERAPY DATE: