BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC DETACHABLE COIL

    MDR report key: 1462051 · Received June 17, 2009

    Report

    Report Number
    2939204-2009-00491
    Event Type
    Malfunction
    Date Received
    June 17, 2009
    Date of Event
    July 1, 2003
    Report Date
    May 18, 2009
    Manufacturer
    BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE AND DEVICE MFR DATE: UNK AS BATCH NUMBER IS UNK. (B) (4) COIL PROTRUSION. ADD'L PMA/510K#: K031049.

    Description of Event or Problem · 1

    PT PURPORTEDLY HAD A RUPTURED LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM IN (B) (6) 2003, TREATED BY ENDOVASCULAR MEANS. DURING THIS TREATMENT, FOLLOWING PLACEMENT OF EIGHT OR NINE COILS, FLUOROSCOPY SHOWED A COIL HAD PROTRUDED OUT OF THE RUPTURED PORTION OF THE ANEURYSM. THIS HAD OCCURRED DURING DETACHMENT, NOT DURING ANY COIL MANIPULATION. HEPARIN WAS REVERSED AND THE CASE WAS COMPLETED. PT HAD SOME EXPANSION OF PERIANEURYSM HEMATOMA WAS EVIDENT ON A POST PROCEDURE CT SCAN, BUT THE PT HAD A GOOD RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC DETACHABLE COIL HCG BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 (MODELS/BATCH/QUANTITY IS UNK)| BOSTON SCIENTIFIC COILS