BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 2625540 · Received September 23, 2009

    Report

    Report Number
    3005168196-2009-00047
    Event Type
    Malfunction
    Date Received
    September 23, 2009
    Date of Event
    September 12, 2009
    Report Date
    September 22, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR OF THIS DEVICE WAS REVIEWED AND IS ATTACHED. CONCLUSION: DEFECT NOTED PRIOR TO SUE. AS PER FDA FEEDBACK OF (B)(4) 2009, THIS DEFECT, IF NOT DISCOVERED, COULD CONTRIBUTE TO INJURY OR DEATH. (B)(6). PART # 2314-04.A. NEURON DC 070 95CMX6CM, SHAPED TIP. LOT # F15459 (SAME AS L15459). QTY: 1. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART #2314-04 (LOT # L15459). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. IN ADDITION, ADD 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 RELEASED MET SPECIFICATIONS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    WHILE UNPACKING THE NEURON DELIVERY CATHETER, A KINK WAS OBSERVED DISTAL OF THE PROTECTIVE HYPO TUBE THROUGH THE STERILE PACKAGING. THE UNIT WAS SET ASIDE FOR RETURN TO THE SUPPLIER AND A NEW CATHETER WAS REMOVED FROM INVENTORY AND THE CASE PROCEEDED WITH NO ADVERSE EVENT. UNFORTUNATELY THE DAMAGED CATHETER WAS DISCARDED AND NOT RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F155551

    Patients

    Seq Age Sex Outcome Treatment
    1