BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 053

    MDR report key: 2842898 · Received November 21, 2012

    Report

    Report Number
    3005168196-2012-00406
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: RESULTS: THERE IS A VISIBLE CRACK IN THE CONICAL SECTION OF THE HUB. THE HUB WAS SEEN TO LEAK SIGNIFICANTLY DURING DECONTAMINATION. THE DAMAGE NOTED IN THE COMPLAINT IS CONFIRMED. CONCLUSION: THE CAUSE OF THE DAMAGE COULD NOT BE DIRECTLY DETERMINED. TYPICALLY, CRACKS IN THE CATHETER HUB ARE CAUSED BY OVER TIGHTENING THE HUB ON A MATING LURE FITTING, BUT THE COMPLAINT DESCRIPTION DOES NOT SUPPORT THIS FINDING BECAUSE THE PHYSICIAN CLAIMED THIS DAMAGE WAS SEEN IN THE PACKAGING. THE CHIPBOARD BOX THAT WAS RETURNED WITH THIS CATHETER SHOWED NO EXTERNAL DAMAGE THAT WOULD EXPLAIN THIS DAMAGE. THE ENVELOPE WAS RETURNED WITHOUT THE CARRIER CARD SO IT COULD NOT BE SIMILARLY EVALUATED. CATHETER HUBS ARE 100% VISUALLY INSPECTED FOR DAMAGE WHILE POUCHING AND WITHOUT OBVIOUS DAMAGE TO THE PACKAGING, IT IS UNLIKELY THAT THIS DAMAGE OCCURRED IN THE BOX AND IT LIKELY OCCURRED DURING USER HANDLING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    THE PHYSICIAN OPENED THE STERILE PLASTIC BAG AND NOTED DAMAGE IN THE HUB OF THE GUIDING CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 053 DQY DQY PENUMBRA, INC. F24625

    Patients

    Seq Age Sex Outcome Treatment
    1