BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET 360 ULTRA 3MM X 8CM

    MDR report key: 2971387 · Received February 21, 2013

    Report

    Report Number
    3008853977-2013-00032
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC CORK, LTD
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS IMPLANTED. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THE DEVICE WAS USED AGAINST INSTRUCTIONS FOR USE. BASED ON THE INVESTIGATION AND THE INFORMATION PROVIDED, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THIS WAS THE SIXTH AND FINAL COIL. THE COIL WAS POSITIONED INSIDE THE ANEURYSM CLOSE TO THE NECK WITH NO ISSUES. DEPLOYMENT INITIATED AND COMPLETED. THE COIL HYPOTUBE WAS BEING SLOWLY REMOVED TO ENSURE APPROPRIATE DETACHMENT BUT COIL WAS STILL ATTACHED TO THE HYPOTUBE. THE PHYSICIAN ATTEMPTED TO PUSH THE COIL BACK INTO THE ANEURYSM BUT THE FORCES MOVED THE MICROCATHETER AWAY FROM THE ANEURYSM SAC AND INTO THE INTERNAL CAROTID ARTERY (ICA). THE COIL IMMEDIATELY DETACHED FROM THE HYPOTUBE WHILE STILL INSIDE THE MICROCATHETER. THE PHYSICIAN TRIED TO REPOSITION THE MICROCATHETER INSIDE THE ANEURYSM BUT IT WAS NOT POSSIBLE AND THE TAIL OF THE COIL PROTRUDED INTO THE PARENT VESSEL. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COIL WITH AN ALLIGATOR SNARE WITHOUT SUCCESS. THE PHYSICIAN THEN DELIVERED A STENT ALONG THE COMMUNICATING AND OPHTHALMIC ICA KEEP THE COIL OPPOSED TO THE VESSEL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76562 TARGET 360 ULTRA 3MM X 8CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC CORK, LTD 15540087

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention