BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON 6F 070 DELIVERY CATHETER

    MDR report key: 3953829 · Received July 23, 2014

    Report

    Report Number
    3005168196-2014-00470
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 23, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE DISTAL TIP OF THE NEURON DELIVERY CATHETER 070 IS PINCHED APPROXIMATELY 1.5, 2.5, AND 4.5 CM FROM THE TIP. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE DISTAL TIP OF THE NEURON DELIVERY CATHETER 070 WAS FOUND DAMAGED IMMEDIATELY AFTER IT WAS REMOVED FROM THE PACKAGE. EVALUATION OF THE RETURNED DEVICE CONFIRMED KINKS IN THE DISTAL TIP OF THE CATHETER. THIS CATHETER IS PACKAGED IN A SHIPPING TUBE TO PROTECT THE CATHETER SHAFT AND TIP FROM DAMAGE. THE DAMAGED SECTIONS APPEAR TO BE PINCHED, WHICH COMMONLY OCCURS DUE TO IMPROPER HANDLING OF THE FLEXIBLE TIP OF THE CATHETER. IN ADDITION, THE DAMAGE PREVENTED THE CATHETER FROM BEING INSERTED INTO THE SHIPPING TUBE. THEREFORE, THIS DAMAGE LIKELY OCCURRED AFTER THE CATHETER WAS REMOVED FROM THE PACKAGING DUE TO MISHANDLING DURING PREPARATION FOR USE. THESE DEVICES ARE 100% VISUALLY INSPECTED DURING PROCESSING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F 070 DELIVERY CATHETER. DURING PREPARATION FOR THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE TIP OF THE NEURON 6F 070 DELIVERY CATHETER WAS DAMAGED. THE DEVICE WAS NOT USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431772 NEURON 6F 070 DELIVERY CATHETER DQY DQY PENUMBRA, INC. F41509

    Patients

    Seq Age Sex Outcome Treatment
    1