BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUGLIELMI DETACHABLE COIL (GDC)

    MDR report key: 1796241 · Received August 11, 2010

    Report

    Report Number
    2939204-2010-00899
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K031049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510#: K031049. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE LABELING FOUND THAT THE DIRECTIONS FOR USE NOTES THAT MULTIPLE PROCEDURES MAY BE REQUIRED TO OCCLUDE AN ANEURYSM. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON THE 434 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT A SECOND PROCEDURE TO OCCLUDE THE ANEURYSM. DURING THIS SECOND PROCEDURE, TWO COILS WERE IMPLANTED. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    434 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT A SECOND PROCEDURE TO OCCLUDE THE ANEURYSM. DURING THIS SECOND PROCEDURE, TWO COILS WERE IMPLANTED. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUGLIELMI DETACHABLE COIL (GDC) DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK UNK534

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)