BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELOCITY DELIVERY MICROCATHETER

    MDR report key: 2923411 · Received January 22, 2013

    Report

    Report Number
    3005168196-2013-00032
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 19, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K100826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULTS: THERE IS A KINK IN THE PROXIMAL PORTION OF THE SHAFT. THIS KINK IS LOCATED APPROXIMATELY 6.9CM FROM THE HUB. CONCLUSION: THE DAMAGE NOTED IN THE COMPLAINT IS CONFIRMED. THIS CATHETER IS KINKED IN THE PROXIMAL PORTION OF THE SHAFT. THE PHYSICIAN NOTED THAT THE CATHETER WAS KINKED UPON REMOVAL FROM THE PACKAGE, HOWEVER THE CAUSE OF THIS DAMAGE CANNOT BE DIRECTLY DETERMINED. THE PACKAGING HOOP SHOULD HAVE PREVENTED THIS DAMAGE IN THE PROXIMAL SHAFT. 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

    THE PHYSICIAN REMOVED THE VELOCITY MICROCATHETER OUT OF THE PROTECTIVE HOOP AND DISCOVERED THAT THE VELOCITY HAD A KINK IN IT. AS NO ADDITIONAL VELOCITY MICROCATHETERS WERE AVAILABLE, AN ALTERNATE MICROCATHETER WAS SELECTED AND USED WITHOUT INCIDENT. THERE WAS NO PATIENT INVOLVEMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29843 VELOCITY DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F28156

    Patients

    Seq Age Sex Outcome Treatment
    1