BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 2043205 · Received February 24, 2011

    Report

    Report Number
    3005168196-2011-00061
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 28, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: THE CATHETER SHOWS A BREAK AT THE BEGINNING OF THE SPIRAL STRAIN RELIEF IN THE PROXIMAL HYPOTUBE AND AT THE DISTAL END OF THE SPIRAL CUT. THE BROKEN DISTAL SECTION OF THE CATHETER IS ATTACHED ONLY BY THE INTERNAL SUPPORT WIRES. THE CATHETER IS NON-FUNCTIONAL. CONCLUSION: THE COMPLAINT STATED THAT THE DAMAGE WAS NOTICED WHEN OPENING THE UNIT. THE UNIT MAY HAVE BEEN DAMAGED DURING PACKAGING, SHIPPING, OR WHEN OPENED AT THE HOSPITAL. HOWEVER, THE DAMAGE WAS CLEARLY VISIBLE THROUGH THE ENVELOPE AND WOULD HAVE BEEN SEEN DURING INSPECTION OF THE CATHETER DURING PACKAGING. IN ADDITION, THE CHIPBOARD BOX SHOWS SOME MINOR CREASE DAMAGE BUT NOTHING IN THE REGION OF THE UNIT DAMAGE. THEREFORE, THE UNIT WAS MOST LIKELY DAMAGED WHEN OPENED AT THE HOSPITAL. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE PROXIMAL HUD END OF A PENUMBRA NEURON DELIVERY CATHETER 070 WAS BROKEN. THE OBSERVATION WAS MADE WHILE OPENING THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 DQY PENUMBRA, INC. F16820

    Patients

    Seq Age Sex Outcome Treatment
    1