BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER

    MDR report key: 4870166 · Received June 25, 2015

    Report

    Report Number
    3005168196-2015-00617
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    May 17, 2015
    Report Date
    May 18, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CORRECTION TO DATE OF THIS REPORT : 5/17/2015

    Additional Manufacturer Narrative · 1

    THE NEURON DELIVERY CATHETER 070 (NEURON 070) WAS FRACTURED APPROXIMATELY 7.5 CM FROM THE DISTAL TIP. THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATED THAT UPON REMOVAL FROM THE PACKAGING, THE NEURON 070 FELL APART AND WAS NOT USED. EVALUATION OF THE RETURNED DEVICE CONFIRMED A FRACTURE IN THE DISTAL SHAFT. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING REMOVAL FROM PACKAGING. IF THE NEURON 070 IS MANIPULATED FORCEFULLY OR AT AN ANGLE DURING REMOVAL FROM THE PACKAGING, THE SHAFT MAY FRACTURE DUE TO EXCESS FORCE AND BENDING. THESE DEVICES ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING PROCESS INSPECTION. 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

    THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F 070 DELIVERY CATHETER. UPON REMOVAL FROM THE PACKAGING, THE NEURON CATHETER WAS FOUND BROKEN AT THE DISTAL END AND WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412511 NEURON DELIVERY CATHETER DQY DQY PENUMBRA, INC. F41008

    Patients

    Seq Age Sex Outcome Treatment
    1