BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENUMBRA SYSTEM

    MDR report key: 1661798 · Received April 16, 2010

    Report

    Report Number
    3005168196-2010-00471
    Event Type
    Other
    Date Received
    April 16, 2010
    Date of Event
    November 30, 2009
    Report Date
    January 4, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFO FROM THE PHYSICIAN CONFIRMING THE UNCERTAIN RELATIONSHIP TO THE DEVICE WAS RECEIVED ON (B)(4) 2010. THE PHYSICIAN CONFIRMED THAT THE DEVICE DID NOT CAUSE ANY VESSEL TRAUMA. HOWEVER, CERTAIN DEVICE RELATIONSHIP CANNOT BE RULED OUT.

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING MECHANICAL THROMBECTOMY WITH THE PENUMBRA SYSTEM. POST-PROCEDURAL CT SCANS DEMONSTRATED A PETECHIAL HEMORRHAGE IN THE BASAL GANGLIA, CLASSIFIED AS AN HI-1 BLEED OF MILD SEVERITY. THIS TYPE OF BLEED IS ALSO KNOWN AS HEMORRHAGIC CONVERSION AND IS COMMON IN SUCH CASES. NO MEDICAL ACTION WAS TAKEN TO ADDRESS THIS BLEED. THE PHYSICIAN REPORTED THAT THE RELATIONSHIP BETWEEN THE HI-1 PETECHIAL HEMORRHAGE AND THE PENUMBRA SYSTEM WAS UNCERTAIN. IN SUBSEQUENT EMAIL MESSAGES THE PHYSICIAN CLARIFIED THAT THE BLEEDS ARE COMMON FOLLOWING FLOW RESTORATION TO AN ISCHEMIC AREA OF BRAIN. THERE WAS NO VESSEL INJURY CAUSED BY THE PENUMBRA DEVICE. HOWEVER, THE RELATIONSHIP TO THE DEVICE IS UNCERTAIN BECAUSE ALL CAUSES OF HEMORRHAGE MAY NOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM PERCUTANEOUS CATHETER NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other