BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET COIL

    MDR report key: 2122329 · Received June 13, 2011

    Report

    Report Number
    2939204-2011-00341
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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. ANEURYSM RUPTURE IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RUPTURED THE ANEURYSM AS IT WAS BEING DEPLOYED INTO THE ANEURYSM. THE COIL WAS IMPLANTED AND THE PHYSICIAN IMPLANTED MORE COILS TO SECURE THE ANEURYSM. THE PATIENT WAS REPORTED TO BE DOING FINE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RUPTURED THE ANEURYSM AS IT WAS BEING DEPLOYED INTO THE ANEURYSM. THE COIL WAS IMPLANTED AND THE PHYSICIAN IMPLANTED MORE COILS TO SECURE THE ANEURYSM. THE PATIENT WAS REPORTED TO BE DOING FINE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET COIL DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M0035473060 14178142

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other