BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC-10 360 SOFT COIL

    MDR report key: 1364521 · Received April 15, 2009

    Report

    Report Number
    2939204-2009-00344
    Event Type
    Injury
    Date Received
    April 15, 2009
    Date of Event
    March 12, 2009
    Report Date
    March 27, 2009
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM CODES. DEVICE CODE: OTHER FOR NO ALLEGATION OF PRODUCT MALFUNCTION OR NON CONFORMANCE CONTRIBUTING TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING THE EMBOLIZATION OF A RUPTURED LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM, A THROMBUS FORMED IN THE PARENT VESSEL. MEDICATION WAS ADMINISTERED, TYPE AND DOSE NOT DISCLOSED. THE THROMBUS WAS RESOLVED WITHOUT ANY RESIDUAL EFFECT. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC-10 360 SOFT COIL HCG NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. M003347306SR0 12034513

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention FIVE GDC COILS (BOSTON SCIENTIFIC)