BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA STROKE SYSTEM

    MDR report key: 1577498 · Received January 7, 2010

    Report

    Report Number
    MW5014280
    Event Type
    Malfunction
    Date Received
    January 7, 2010
    Report Date
    January 7, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PENUMBRA INC. PART NUMBER 0854 -0.032 CATHETER- QUALITY FAILED TO MEASURE A CRITICAL DIMENSION ON PART PER DRAWING -HUB IC-. THIS WAS DISCOVERED IN 2009 AND PLACED ON NCR. THIS OVERSIGHT HAS YET TO BE CORRECTED, AND THE PART IS STILL BEING IMPROPERLY INSPECTED. SINCE 2007, THIS HAS EFFECTED RELEASED LOTS. DATES OF USE: 2007 - 2010 (TO PRESENT). DIAGNOSIS OR REASON FOR USE: ISCHEMIC STROKE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA STROKE SYSTEM REPROFUSION CATHETER 0.032 NRY PENUMBRA, INC. ALL

    Patients

    Seq Age Sex Outcome Treatment
    1