BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROFILL 10-SYSTEM COIL

    MDR report key: 4142818 · Received September 23, 2014

    Report

    Report Number
    2032493-2014-00070
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: THE DEVICE WAS RETURNED FOR EVALUATION AND THE IMPLANT COIL WAS FOUND DETACHED. EVALUATION OF THE IMPLANT COIL AND DELIVERY PUSHER REVEALED EXCESSIVE FORCE WAS USED; WHEN THIS OCCURRED, IT LIKELY LED TO THE COIL BECOMING DETACHED. (B)(4).

    Description of Event or Problem · 1

    COILING TREATMENT WAS CONDUCTED OF AN ANEURYSM LOCATED IN THE VERTEBRAL ARTERY. IT WAS REPORTED DURING COIL DELIVERY, RESISTANCE ENCOUNTERED AND THE COIL SUBSEQUENTLY STRETCHED. UPON REMOVAL, THE COIL DETACHED IN THE BASILAR ARTERY AND WAS SUCCESSFULLY RETRIEVED WITH A SOLITAIRE RETRIEVAL DEVICE. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591099 HYDROFILL 10-SYSTEM COIL EMBOLIZATION COIL HCG MICROVENTION, INC. 100510HFIL-V 14060403

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention