BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURON DELIVERY CATHETER 070 ADVANCED

    MDR report key: 2625560 · Received October 13, 2009

    Report

    Report Number
    3005168196-2009-00073
    Event Type
    Other
    Date Received
    October 13, 2009
    Date of Event
    September 15, 2009
    Report Date
    September 15, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED IN ITS CHIPBOARD BOX AND INTACT STERILE SHEATH. THERE WAS NO PT CONTACT AND THE UNIT WAS NOT DECONTAMINATED. THE BOX SHOWS A CREASE AND CRUSH MARKS BETWEEN 15 AND 18 CM FROM THE HUB END OF THE CHIPBOARD BOX. THERE IS A SMALL CREASE IN THE STERILE SHEATH IN THE CORRESPONDING LOCATION ON THE INNER ENVELOPE. WITHOUT OPENING THE STERILE SHEATH, NO DAMAGE TO THE UNIT CAN BE DETECTED. THE DEVICE TIP IS CLEARLY VISIBLE AND NOT MALFORMED. ONCE THE STERILE SHEATH WAS OPENED, A SINGLE AXIS BEND COULD BE CLEARLY SEEN 9.8 CM DISTAL OF THE HUB/SHAFT TRANSITION. CONCLUSION (OTHER): DEFECT NOTED PRIOR TO USE. AS PER FDA FEEDBACK OF (B)(4) 2009, THIS DEFECT, IF NOT DISCOVERED, COULD CONTRIBUTE TO INJURY OR DEATH. COMPLAINT/INCIDENT FINDINGS: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # (B)(4), (LOT # L15595). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WERE REQUIRED. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. ALL PARTS THAT FAILED VISUAL INSPECTION HAVE BEEN REJECTED AND ALL PARTS MEETING SPECIFICATIONS WERE RELEASED FOR SHIPMENT. THE PARTS RELEASED IN THESE LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE PACKAGE WAS DAMAGED UPON DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 ADVANCED PERCUTANEOUS CATHETER DQY PENUMBRA, INC. PND6F0701058M 15595

    Patients

    Seq Age Sex Outcome Treatment
    1