BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2181120 · Received July 8, 2011

    Report

    Report Number
    3005168196-2011-00274
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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. THE MFG RECORDS FOR THIS LOT HAVE BEEN REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE TECHNOLOGIST COMMENTED THAT THE PENUMBRA COIL 400 WAS DIFFICULT TO LOAD INTO THE PX 400 MICROCATHETER. THE COIL WAS NOT PLACED IN THE BODY AND AN ALTERNATE COIL OF THE SAME SIZE WAS USED AND SUCCESSFULLY TREATED THE ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F19884

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR