BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SEPARATOR 032

    MDR report key: 1830711 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00176
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    June 2, 2008
    Report Date
    June 27, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN TRACKED A REPERFUSION CATHETER 032 TO THE M1 SEGMENT. THERE WAS A TIGHT BEND IN THE CAVERNOUS SEGMENT OF THE CAROTID ARTERY. ONCE THE SEPARATOR 032 WAS ADVANCED, IT COULD NOT ADVANCE BEYOND THIS BEND IN THE REPERFUSION CATHETER 032. THE PHYSICIAN RETRIEVED ALL UNITS AND NOTED THERE WAS NO PATIENT INJURY AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SEPARATOR 032 PERCUTANEOUS CATHETER NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1