BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 3885104 · Received June 19, 2014

    Report

    Report Number
    3005168196-2014-00404
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION AS THE DEVICE WAS IMPLANTED IN THE PATIENT. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. DEVICE WAS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE USING A PENUMBRA COIL 400. DURING THE PROCEDURE, THE COIL DETACHED DURING REPOSITIONING. THE COIL WAS PLACED BY FLUSHING AND PUSHING WITH THE WIRE. THE COIL WAS IMPLANTED IN THE PATIENT AND THE PUSHER WAS DISPOSED OF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361245 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F36825

    Patients

    Seq Age Sex Outcome Treatment
    1