BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PX SLIM DELIVERY MICROCATHETER

    MDR report key: 3150745 · Received June 6, 2013

    Report

    Report Number
    3005168196-2013-00212
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K100826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE CATHETER HAS A KINK IN THE HYPO-TUBE DISTAL OF THE ID BAND APPROXIMATELY 2.3CM FROM THE HUB. THE CATHETER IS NON-FUNCTIONAL. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT STATES THAT PXSLIM CATHETER KINKED IN THE STRAIN RELIEF PORTION OF THE HUB. IF THE CATHETER IS MISHANDLED DURING USE IT IS POSSIBLE THAT DAMAGE MAY OCCUR. IT APPEARS THAT THE PROXIMAL END OF THE CATHETER WAS MANIPULATED IN SUCH A WAY THAT THE FORCE PLACED ON THE PROXIMAL STRAIN RELIEF WAS GREATER THAN THE STRENGTH OF THE MATERIAL. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-00211.

    Description of Event or Problem · 1

    PHYSICIAN ACCESSED CCF VIA VENOUS APPROACH WITH PX SLIM MICROCATHETER. AFTER ONE HOUR AND HAVING PLACED THREE PENUMBRA COIL 400 COILS, THE STRAIN-RELIEF PORTION OF THE HUB ON THE MICROCATHETER WAS KINKED, AND APPEARED TO BE FRACTURED. SALINE WAS NOTED TO BE DRIPPING FROM THE SITE OF THE KINK UPON FLUSHING THE MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249915 PX SLIM DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F32317

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR