BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVRY CATHETER 053

    MDR report key: 1641699 · Received March 16, 2010

    Report

    Report Number
    3005168196-2010-00303
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    March 3, 2009
    Report Date
    March 4, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECH EVAL: DURING FLUSHING OF THE RETURNED UNIT, LEAKAGE WAS OBSERVED IMMEDIATELY ADJACENT TO THE LUER FITTING. EXAMINATION OF THE LUER FITTING REVEALED AN INCOMPLETE MOLD AND CRACKS RADIATING FROM THE MISSING PORTION. CONCLUSION: THE LEAKAGE REPORTED WAS CONFIRMED. THE CAUSE OF THE LEAKAGE WAS THE BROKEN MOLDED LURE FITTING. THE DHR FOR THIS MFR LOT WAS REVIEWED. THE MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEB 2010 UPDATE TO THE FDA WARNING LETTER DATED DEC 31, 2009. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART# 1147-04 (LOT# L13653) AND SUB-ASSEMBLY PN 0918-04/D (LOT# L12897). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WERE REQUIRED. IN ADDITION, ALL DESTRUCTIVE TESTING WERE COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPEC FOR THE TENSILE STRENGTH. ALL PARTS THAT FAILED VISUAL INSPECTION HAVE BEEN REJECTED AND ALL PARTS RELEASED MET SPECS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN REMOVED A NEURON FROM ITS POUCH AND FLUSHED IT DURING PREPARATION FOR A CASE, HE NOTICED A LEAK AT THE PROXIMAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVRY CATHETER 053 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F13653

    Patients

    Seq Age Sex Outcome Treatment
    1