BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070 ADVANCED

    MDR report key: 1544842 · Received November 9, 2009

    Report

    Report Number
    3005168196-2009-00095
    Event Type
    Malfunction
    Date Received
    November 9, 2009
    Date of Event
    October 15, 2009
    Report Date
    October 15, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: THE FIRST 0.5 CM OF THE DISTAL TIP WAS COMPLETELY FLATTENED AND THERE WERE SINGLE AXIS BENDS AT 1.8 AND 2.5CM. THERE WAS ALSO A LONGER FLATTENED SPOT BETWEEN 4.5 AND 6.2CM FROM THE TIP. THE INCIDENT IS CONFIRMED AS REPORTED. IT SHOULD BE NOTED THAT BOTH THE TIP FLATTENING AND THE SINGLE AXIS BENDS ARE UNUSUAL FOR THIS SORT OF FAILURE AND ARE LIKELY THE RESULT OF INATTENTIVE HANDLING AFTER THE INCIDENT. FLATTENED CATHETER TIPS ARE REPORTABLE INCIDENTS PER FDA GUIDANCE AS OF 28 AUG 2009 (INCLUDING OUT-OF-BOX FAILURES). A DHR OF THIS MFG LOT HAS BEEN REVIEWED. QTY: 1. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 2314-03, (LOT # L15514). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. IN ADDITION, ALL DESTRUCTIVE TESTING WAS 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 MEETING SPECS WERE RELEASED FOR SHIPMENT. LOT# L15514 WAS ASSOCIATED WITH (B)(4) DUE TO "SHORT-SHOTS" IN THE HUB MOLDING PROCESS. THIS (B)(4) HAS NOT BEEN FOUND TO BE RELATED TO THIS INCIDENT WHICH INVOLVED THE NEURON TIP, NOT THE HUB. THE PARTS RELEASED IN THESE LOTS MET PROCESS REQUIREMENTS.

    Description of Event or Problem · 1

    THE TIP OF THE NEURON 070 WAS FOUND TO BE FLATTENED UPON OPENING THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 ADVANCED SUBCUTANEOUS CATHETER DQY PENUMBRA, INC. F15514

    Patients

    Seq Age Sex Outcome Treatment
    1