BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 3090564 · Received May 2, 2013

    Report

    Report Number
    3005168196-2013-00157
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. 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 CANNOT BE FOUND.

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING ELECTIVE LEFT ICA ANEURYSM EMBOLIZATION TREATMENT. WHILE PHYSICIAN WAS ATTEMPTING TO PLACE PENUMBRA COIL 400 6X15 COMPLEX SOFT FINISHING COIL THE CATHETER BACKED OUT OF THE ANEURYSM. THE PHYSICIAN THEN ATTEMPTED TO SLIDE THE PXSLIM MICROCATHETER OVER THE COIL SEVERAL TIMES. THIS APPEARED TO PUT TOO MUCH PRESSURE ON THE COIL AND IT WAS SUBSEQUENTLY DETACHED WHILE PARTIALLY INSIDE THE PXSLIM MICROCATHETER. THE PHYSICIAN THEN USED A GOOSE NECK SNARE TO RETRIEVE THE COIL WITHOUT INCIDENT OR ANY HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192746 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F32321

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention