BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1589065 · Received January 19, 2010

    Report

    Report Number
    3005168196-2010-00052
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    April 20, 2009
    Report Date
    April 23, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THERE ARE KINKS IN THE PROXIMAL END AT 6.7, 32.8 AND 38.4 CM FROM THE YELLOW ID MARKER. AT THE DISTAL TIP, THERE IS A SINGLE AXIS BEND AT 3.0 CM FROM THE DISTAL MARKER BAND. THERE ARE ALSO FLAT SPOTS AT 3.6-4.5 CM, 5.0 TO 5.8 CM AND 11.3-12.0 CM. FINALLY, THERE IS A SINGLE AXIS BEND AT 14.0 CM FROM THE MARKER BAND. THE DAMAGE OBSERVED AGREES WITH THE INCIDENT AS REPORTED. IT IS UNCLEAR HOW MUCH OF THE DAMAGE OCCURRED DURING USE, AND HOW MUCH IS THE RESULT OF SUBSEQUENT HANDLING AND TRANSPORT. THE LOCATION OF THE KINK THAT IS THE CAUSE OF THIS INCIDENT IS NOT CLEARLY IDENTIFIED IN THE INCIDENT REPORT. THE DHR OF THIS MFG LOT HAS BEEN REVIEWED AND IS ATTACHED. 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 #1626-02.B, (LOT # L14007). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WERE REQUIRED. THE DHR REVIEW OF FINAL ASSEMBLY (LOT# L14007) 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. THE LOT WAS ASSOCIATED WITH (B)(4) FOR THREE YEARS ACCELERATED AGING DATA NOT BACK YET. THE PRODUCT WAS BUILT AT RISK AND RELEASED WHEN THE SHELF LIFE DATA WAS RECEIVED AND THE DEVIATION WAS CLOSED. THE LOT WAS ASSOCIATED WITH (B)(4) TO PRINT ADD'L LABELS AT REVISION B. THE LOT WAS ASSOCIATED WITH (B)(4) FOR PRODUCT THAT WAS LABELED WITH A CE MARK BUT NOT IN A CONFIGURATION THAT WAS CLEARED FOR CE MARK. THE LOT WAS ASSOCIATED WITH (B)(4) FOR FAILURE TO FOLLOW SCRAP/REWORK TICKET FOR (B)(4) .

    Description of Event or Problem · 1

    THE NEURON 070 KINKED DURING THE PROCEDURE. THE CASE WAS COMPLETED WITH A DIFFERENT GUIDE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F14007

    Patients

    Seq Age Sex Outcome Treatment
    1