BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2013654 · Received February 4, 2011

    Report

    Report Number
    3005168196-2011-00058
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    March 27, 2008
    Report Date
    April 22, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING REVIEW: THE SEPARATOR HAD MULTIPLE BENDS APPROXIMATELY 1 CM DISTAL TO THE TAPER. CONCLUSION: DURING USE, THE SEPARATOR WAS MOVED PROXIMALLY TO A POINT WHERE THE TAPER EXITED THE VALVE OF THE RHV. WHEN THE SEPARATOR WAS THEN ADVANCED, THE SMALLER DIAMETER WORKING LENGTH PORTION, DISTAL TO THE TAPER, BENT. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THREE SEPARATE WIRES KINKED AT THE TRANSITION ZONE. UPON ADVANCING THE WIRE INTO AND OUT OF THE CATHETER HUB, THE WIRE KINKED AT THE TRANSITION ZONE. NO PATIENT INJURY OCCURRED. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-00160 AND MDR 3005168196-2011-00032.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 032 PERCUTANEOUS CATHETER NRY PENUMBRA, INC. F12342

    Patients

    Seq Age Sex Outcome Treatment
    1