BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON MAX 6F 088 LONG SHEATH

    MDR report key: 5427953 · Received February 10, 2016

    Report

    Report Number
    3005168196-2016-00130
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Report Date
    January 11, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K111380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2016-00146, 2. 3005168196-2016-00129, 3. 3005168196-2016-00142. THE HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE CROSS-CUT VALVE OF THE NEURON MAX DID NOT PROPERLY SEAL AND BLOOD BEGAN TO OOZE OUT. THE COMPONENT USED TO TIGHTEN THE CROSS-CUT VALVE TO THE NEURON MAX WOULD NOT TIGHTEN AND CONTINUED TO SPIN AROUND WITHOUT LOCKING TIGHT. THE PROCEDURE WAS COMPLETED BY REPLACING THE CROSS-CUT VALVE WITH ANOTHER MANUFACTURER'S CROSS-CUT VALVE. PLEASE NOTE THAT THE DATE OF EVENT, PATIENT INFORMATION AND DEVICE INFORMATION WERE NOT PROVIDED. THE MANUFACTURER HAS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84213 NEURON MAX 6F 088 LONG SHEATH DQY DQY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1