BEUDAMED
    FDA Adverse Event Death Summary report: N

    TARGET COIL

    MDR report key: 2830223 · Received November 13, 2012

    Report

    Report Number
    2939204-2012-00326
    Event Type
    Death
    Date Received
    November 13, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REMAINED IMPLANTED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, PATIENT OUTCOME OF DEATH IS NOTED IN THE DIRECTION FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN ANTERIOR COMMUNICATING ARTERY ANEURYSM COILING, A PATIENT DEATH OCCURRED. NO FURTHER INFORMATION WAS PROVIDED AS TO THE CAUSE OF THE DEATH OR THE RELATIONSHIP TO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN ANTERIOR COMMUNICATING ARTERY ANEURYSM COILING A PATIENT DEATH OCCURRED. NO FURTHER INFORMATION WAS PROVIDED AS TO THE CAUSE OF THE DEATH OR THE RELATIONSHIP TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET COIL DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK UNK595

    Patients

    Seq Age Sex Outcome Treatment
    1 Death TWO TARGET COILS (BOSTON SCIENTIFIC)