BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC DETACHABLE COIL

    MDR report key: 1558722 · Received November 23, 2009

    Report

    Report Number
    2939204-2009-00852
    Event Type
    Malfunction
    Date Received
    November 23, 2009
    Report Date
    November 2, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). COIL PROTRUSION. ADD'L PMA/510K: K031049.

    Description of Event or Problem · 1

    DURING PROCEDURE, THE COIL BROKE DUE TO PRESSURE APPLIED TO THE MICROCATHETER. THEREFORE, THE PROXIMAL END OF THE COIL PROTRUDED FROM THE ANEURYSM. NO RETRIEVAL TECHNIQUE WAS PERFORMED BY THE PHYSICIAN AND NO PATIENT COMPLICATIONS WERE REPORTED. NO OTHER INFORMATION CONCERNING THIS EVENT WAS DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC DETACHABLE COIL HCG BOSTON SCIENTIFIC CORPORATION UNK534 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER (UNKNOWN BRAND AND MANUFACTURER)