BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1589043 · Received January 19, 2010

    Report

    Report Number
    3005168196-2010-00059
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    April 22, 2009
    Report Date
    April 22, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THE CATHETER IS BENT IN 3 PLACES THAT APPEAR TO BE POST USE HANDLING DAMAGE. THESE BENDS ARE 16, 72 AND 78 CM FROM THE HUB SHAFT JOINT. JUST TO THE PROXIMAL SIDE OF THE FLEXIBLE DISTAL TRANSITION, THERE IS A FLAT SPOT (13.0 - 14.0 CM FROM THE TIP). THERE IS A TWISTED FLAT SPOT BETWEEN 7.0 AND 8.5 CM FROM THE TIP AND THE FIRST 0.5 CM OF THE DISTAL END IS OVALIZED. THE INCIDENT IS CONFIRMED AS REPORTED. THE CATHETER APPEARS TO HAVE COLLAPSED WHILE INSIDE THE PT. 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 (B)(4) 2009. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 1626-02.B, (LOT # L14047). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WERE REQUIRED. THE DHR REVIEW OF FINAL ASSEMBLY (LOT# L14047) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN (B)(4) REJECTS FOR VISUAL AND DIMENSIONAL MEASUREMENT. ALL PARTS THAT FAILED INSPECTION HAVE BEEN REJECTED AND ALL PARTS RELEASED MET SPECIFICATIONS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. (B)(4). THE PRODUCT WAS BUILT AT RISK AND RELEASED WHEN THE SHELF LIFE DATA WAS RECEIVED AND THE DEVIATION WAS CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE NEURON CATHETER WAS ADVANCED INTO THE PETROUS PORTION OF THE ICA. AFTER PLACEMENT OF THE NEURON, THE PHYSICIAN THEN REMOVED THE GUIDE WIRE AND TRIED TO ADVANCE A MICRO CATHETER INTO THE NEURON. THE MICRO CATHETER WOULD NOT ADVANCE. UPON INSPECTION OF THE NEURON ON FLUORO, A SEVERE KINK WAS OBSERVED APPROX 12CM FROM THE DISTAL TIP. THE PRODUCT IS BEING RETURNED FOR EVALUATION. THERE WAS NO PT INJURY ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F14047

    Patients

    Seq Age Sex Outcome Treatment
    1