BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1589036 · Received January 19, 2010

    Report

    Report Number
    3005168196-2010-00050
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    February 12, 2009
    Report Date
    February 12, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Removal / Correction Number
    Z-0001-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THE UNIT WAS FLUSHED WITH A BLEACH DILUTION AND IT WAS NOTICED THAT THERE WAS LEAKING AT THE FLEXIBLE TIP JOINT. THERE IS A KINK 12.5CM FROM THE TIP (WHERE THE LEAKING OCCURRED). THERE IS A FLATTENED SECTION BETWEEN 16 AND 17CM FROM THE TIP AND SMALL KINKS AT 17.5 AND 19.5CM FROM THE TIP. THERE ARE SINGLE AXIS BENDS AT 23CM FROM THE TIP AND 37.5CM FROM THE DISTAL END OF THE YELLOW BAND. THE KINKS OBSERVED DURING THE PROCEDURE WERE CONFIRMED. THE LEAK OBSERVED DURING DECONTAMINATION WAS NOT PART OF THE ORIGINAL COMPLAINT AND MAY HAVE OCCURRED DUE TO THE DECONTAMINATION PROCESS. THE DHR OF THIS MFG LOT HAS BEEN REVIEWED. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN IN RESPONSE TO THE 483 ISSUED TO PENUMBRA ON 08/28/2009. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 1626-01.A, (LOT # L14150). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WERE REQUIRED. THIS LOT WAS ASSOCIATED WITH (B)(4) WHICH WAS A BUILD AT RISK WITH 3 YEAR SHELF LIFE PRIOR TO THE 3 YEAR ACCELERATED AGING DATA RETURNING. THESE LOTS WERE HELD IN QUARANTINE UNTIL THE DATA RETURNED. THIS LOT WAS ASSOCIATED WITH (B)(4) FOR A PARTICLE FOUND IN A SINGLE POUCH. THE UNIT WAS REPROCESSED. THE DHR REVIEW OF FINAL ASSEMBLY (LOT# L14150) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN (B)(4)REJECTS. ALL PARTS THAT FAILED VISUAL INSPECTION HAVE BEEN REJECTED, AND ALL PARTS RELEASED MET SPECIFICATIONS. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    THE NEURON 070 KINKED IN THREE PLACES DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F14150

    Patients

    Seq Age Sex Outcome Treatment
    1