BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC-10 360 COIL

    MDR report key: 1222098 · Received November 5, 2008

    Report

    Report Number
    2939204-2008-00553
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 30, 2008
    Report Date
    October 30, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WAS REQUESTED FROM THE USER FACILITY. BASED ON THE INFO RECEIVED THE FOLLOWING WAS DETERMINED: CONTINUOUS FLUSH WAS MAINTAINED AND ALL MOVEMENTS WERE SLOW AND SMOOTH AND OBSERVED UNDER FLUOROSCOPY, IN ACCORDANCE WITH THE DIRECTIONS FOR USE. THE PHYSICIAN DID NOT EXPERIENCE ANY RESISTANCE ADVANCING THE DEVICE THROUGH THE MICROCATHETER. THERE WAS NO ATTEMPT MADE TO DETACH THE DEVICE IN THE ANEURYSM.

    Description of Event or Problem · 1

    AS THE PHYSICIAN WAS ATTEMPTING TO WITHDRAW THE DEVICE INTO THE MICROCATHETER TO REPOSITION IT WITHIN THE ANEURYSM WHEN IT BECAME "KNOTTED" AND JAMMED. THE PHYSICIAN WAS REMOVING THE DEVICE WITH THE MICROCATHETER AS ONE UNIT WHEN THE DEVICE PREMATURELY DETACHED IN THE FEMORAL ARTERY. THE DEVICE MIGRATED TO THE LEFT COMMON FEMORAL ARTERY AND WAS SUCCESSFULLY REMOVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH OTHER COILS AND THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC-10 360 COIL (HCG) DETACHABLE COIL HCG NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. 3461030-SR 11890027

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention BOSTON SCIENTIFIC))| AMPLATZ SNARE (MFR UNK)| PROWLER SELECT MICROCATHETER (CORDIS| COILS (NUMBER UNK)