BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM SEPARATOR 041

    MDR report key: 3971906 · Received July 31, 2014

    Report

    Report Number
    3005168196-2014-00492
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    September 9, 2012
    Report Date
    July 1, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DISSECTION IS A KNOWN AND ANTICIPATED COMPLICATION WITH THESE TYPES OF PROCEDURES AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00491. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    FIVE MONTHS FOLLOWING A SUCCESSFUL THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (M2 REGION) USING A PENUMBRA SYSTEM REPERFUSION CATHETER 041 AND A PENUMBRA SYSTEM SEPARATOR 041, A MAGNETIC RESONANCE ANGIOGRAM (MRA) INDICATED THAT THE PATIENT DEVELOPED A DISSECTING ANEURYSM IN THE DISTAL PART OF THE NARROWED M1; THEREFORE, COIL EMBOLIZATION WAS PERFORMED. APPROXIMATELY 14 MONTHS LATER, THE PATIENT DEVELOPED ANOTHER ANEURYSM AND UNDERWENT ANOTHER COIL EMBOLIZATION. THE PHYSICIAN'S COMMENT: I MIGHT BRING DAMAGE TO THE BLOOD VESSEL WITH THE CATHETER OR THE SEPARATOR WHILE REMOVING THE THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446956 PENUMBRA SYSTEM SEPARATOR 041 NRY NRY PENUMBRA, INC. F24298

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention