BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUSPHERE 10 - PLATINUM MICROCOIL

    MDR report key: 2955769 · Received February 11, 2013

    Report

    Report Number
    1226348-2013-20015
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. WITH REVIEW OF THE AVAILABLE INFORMATION AND AS REPORTED, CLINICAL FACTORS INCLUDING THE ANEURYSM MORPHOLOGY CONTRIBUTED TO THE LOOPS OF THE COIL LOOPS PROLAPSING INTO THE PARENT VESSEL DURING PLACEMENT. THIS AND DEVICE INTERACTION ALSO CONTRIBUTED TO THE PROTRUSION OF THE LAST COIL. WITH REVIEW OF THE REPORTED INFORMATION AND THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, AFTER POSITION 80% OF THE 2X2.5 MICROSPHERE MICROCOIL (SPH10020020/C12087) IN A 3.1X2.1MM OPHTHALMIC ANEURYSM THROUGH THE SL10 MICROCATHETER, THE LAST 20% KEPT PUSHING/KICKING OUT THE MICROCATHETER BACK OUT OF THE ANEURYSM. AN INTERMEDIATE CATHETER WAS ADDED FOR ADDITIONAL SUPPORT AND TRIED AGAIN WITH THE SAME RESULT. THEE PROCEDURE WAS COMPLETED USING EV3 COILS. THE VESSEL HAD MODERATE TORTUOUSITY. THERE WAS NO PATIENT INJURY AND DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59680 MICRUSPHERE 10 - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C12087

    Patients

    Seq Age Sex Outcome Treatment
    1 INTERMEDIATE CATHETER DAC 044 AND NEURON 070