BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA 6F NEURON DELIVERY CATHETER 070

    MDR report key: 3090675 · Received May 2, 2013

    Report

    Report Number
    3005168196-2013-00164
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE CATHETER IS KINKED IN THE PROXIMAL PORTION OF THE SHAFT. THESE KINKS ARE LOCATED IN THE HYPO-TUBE AREA APPROXIMATELY (3.5CM) AND (5.5CM) DISTAL TO THE HUB. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT DESCRIBED THAT THE CATHETER WAS KINKED IN THE PACKAGE. THIS DEVICE IS PACKAGED IN A PROTECTIVE SHIPPING TUBE TO PREVENT THIS TYPE OF DAMAGE, HOWEVER, THE PRODUCT WAS NOT RETURNED IN ITS ORIGINAL PACKAGING. THEREFORE, THE CONDITION OF THE ORIGINAL PACKAGING CANNOT BE EVALUATED. THIS TYPE OF DAMAGE IS CONGRUENT WITH MISHANDLING DURING REMOVAL OF PRODUCT FROM PACKAGING. PRODUCTS FROM THIS LOT WERE 100% VISUALLY INSPECTED PRIOR TO SHIPMENT. 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

    WHILE PATIENT WAS ON TABLE WAITING TO BE TREATED THE LAB MANAGER NOTICED THERE WAS A KINK IN THE CATHETER PACKAGE. IT WAS NOT USED IN THE PATIENT, AND NO PATIENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191125 PENUMBRA 6F NEURON DELIVERY CATHETER 070 DQY DQY PENUMBRA, INC. F26450

    Patients

    Seq Age Sex Outcome Treatment
    1