BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYSROCOIL (HES) 14-SYSTEM COIL

    MDR report key: 2193488 · Received July 13, 2011

    Report

    Report Number
    2032493-2011-00017
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 11, 2011
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. THE ROOT CAUSE OF THIS COMPLAINT CAN NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL DISCREPANCIES OR NON-CONFORMANCES WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEPLOYMENT OF AN EMBOLIZATION COIL, THE COIL DID NOT DETACH. THE COIL WAS RETRIEVED FROM THE PT. HOWEVER, IT IS NOT KNOWN IF THE COIL WAS RETRACTED INTO THE MICROCATHETER OR IF A RETRIEVAL DEVICE WAS USED. NO ADD'L INFO COULD BE PROVIDED. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYSROCOIL (HES) 14-SYSTEM COIL EMBOLIZATION COIL HCG MICROVENTION, INC. 140620HES-V P101018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention