BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPLEX 10-SYSTEM COIL (MCS)

    MDR report key: 3832363 · Received February 10, 2014

    Report

    Report Number
    2032493-2014-00013
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Date of Event
    December 19, 2013
    Report Date
    January 16, 2014
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: A VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED FINDINGS THAT WERE NOT CONSISTENT WITH THE COMPLAINT REPORTED. THE DEVICE RETURNED HAD THE IMPLANT ATTACHED TO THE DELIVERY PUSHER. THE IMPLANT WAS SLIGHTLY STRETCHED AND KINKED AT THE PROXIMAL END. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED BASED ON THE INFO PROVIDED. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL DISCREPANCIES OR NON-CONFORMANCES WERE OBSERVED.

    Description of Event or Problem · 1

    DURING THE TREATMENT OF AN A-COMM ANEURYSM, THE EMBOLIZATION COIL WAS DEPLOYED WITHIN THE ANEURYSM. UPON FURTHER MANIPULATION OF THE MICROCATHETER TO POSITION THE LAST COIL LOOP, THE COIL DETACHED. A SMALL PORTION OF THE LAST COIL LOOP PROTRUDED INTO THE PARENT VESSEL. NO ATTEMPTS WERE MADE TO RETRIEVE THE COIL. NO PT WAS REPORTED TO HAVE NO DEFECTS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87912 MICROPLEX 10-SYSTEM COIL (MCS) EMBOLIZATION COIL HCG MICROVENTION, INC. 100204HS-V 110328M

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR