BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM

    MDR report key: 1757235 · Received June 18, 2010

    Report

    Report Number
    3005168196-2010-00512
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Date of Event
    May 21, 2010
    Report Date
    May 21, 2010
    Manufacturer
    PENUMBRA INC.
    Product Code
    DQY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO REVASCULARIZE A TORTUOUS OCCLUDED VESSEL USING THE PENUMBRA SYSTEM. THE PHYSICIAN REACHED THE SITE OF THE OCCLUSION AND USED THE PENUMBRA STROKE SYSTEM FOR "A FEW MOMENTS" THEN STOPPED USING THE PENUMBRA SYSTEM AND PROCEEDED WITH LYTICS. MOMENTS LATER, AN SAH BLEED WAS DISCOVERED. THE PATIENT WAS DISCHARGED AND RECOVERING. AS OF (B)(6) 2010: THE EVENT WAS STATED AS HAVING A "PROBABLE" RELATIONSHIP TO THE STUDY DEVICE AND IS "UNRELATED" TO THE ANGIOGRAPHIC PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1