BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400 DETACHMENT HANDLE

    MDR report key: 2040303 · Received February 15, 2011

    Report

    Report Number
    3005168196-2011-00104
    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

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    ONCE THE COIL WAS DEPLOYED, THE PHYSICIAN HAD TROUBLE REMOVING THE PUSHER ASSEMBLY (WIRE) FROM THE HANDLE. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00105.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 DETACHMENT HANDLE HCG, KRD HCG PENUMBRA, INC. F17472

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR