BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2040304 · Received February 15, 2011

    Report

    Report Number
    3005168196-2011-00105
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PREMATURE COIL DETACHMENT OCCURRED LATE IN THE CASE. BOTH COMPRESSION AND TENSION RESISTANCE WERE INVOLVED. THE COIL CHOSEN WAS TOO LARGE FOR THE ANEURYSM AND THIS MAY HAVE CAUSED THE COMPRESSION AND TENSION RESISTANCE ON THE COIL DURING MANIPULATION AND REPOSITIONING WHICH MAY HAVE LEAD TO THE PREMATURE DETACHMENT. THE COILED WAS REMOVED FROM THE PT. THE PUSHER ASSEMBLY AND THE COIL ARE NOT AVAILABLE FOR RETURN. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-000104.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F18092

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR