BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1588947 · Received January 19, 2010

    Report

    Report Number
    3005168196-2010-00034
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    December 9, 2008
    Report Date
    December 9, 2008
    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 EVAL: THE DEVICE HAS FLAT SECTIONS AT 2.5, 5.0 AND 8.0CM FROM THE TIP. THERE IS A KINK AT 6.5CM FROM THE TIP AND, AS DESCRIBED IN THE INCIDENT, A KINK 13.5 CM FROM THE TIP AND 22 CM FROM THE TIP. THE SHARP KINK AT 13.5CM FROM THE TIP IS LOCATED AT THE END OF THE TIE LAYER JUNCTION TO THE PEBAX 72D TUBING. THE KINK MAY HAVE BEEN CAUSED BY THE TORTUROUS ANATOMY OF THE SUBJECT. THE DEVICE MAY HAVE BEEN TOO FAR IN AN ANGLE THAT WOULD NOT ALLOW IT TO PASS THROUGH THE AORTIC ARCH. THE REPETITIVE MOVEMENT OF THE DEVICE DURING THE CASE WOULD HAVE CAUSED THE CATHETER TO SCISSOR ITSELF AND KINK. 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 AUGUST 28, 2009. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART #1626-02 NEURON DELIVERY CATHETER 070 (95CM X 6 CM) STRAIGHT TIP, LOT NUMBER L13899. THE DHR REVIEW OF FINAL ASSEMBLY (LOT# L13899) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN (B)(4) REJECTS. ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPEC FOR THE TENSILE STRENGTH. A REVIEW OF THE COIL SUB-ASSEMBLY LOTS USED TO MANUFACTURE LOT L13899 SHOW NO ANOMALIES WITH THE MFG PROCESS, HOWEVER, SOME UNITS HAVE BEEN REJECTED DURING VISUAL INSPECTION L13815 ((B)(4) REJECTS); L13816 ((B)(4) REJECTS); L13849 ((B)(4) REJECT); THE 3 LOTS PASSED ALL THE REQUIRED VISUAL INSPECTION AND DIMENSIONAL MEASUREMENTS. ALL PARTS THAT FAILED VISUAL INSPECTION HAVE BEEN REJECTED AND ALL PARTS RELEASED MET SPECS. NO OTHER ANOMALIES WERE FOUND WITH THIS LOT DUE TO THE MFG PROCESS. THE PART RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    AFTER THE PLACEMENT OF THE NEURON 070, THE CATHETER KINKED ABOUT 14CM DISTAL TO THE TIP AROUND THE AORTIC ARCH. THE PHYSICIAN WAS ABLE TO COMPLETE THE CASE WITH THE KINKED CATHETER, INCLUDING COILING AND BALLOON PROCEDURES. AFTER THE COMPLETION OF THE CASE, THE PHYSICIAN REMOVED THE NEURON AND NOTICED THAT THERE WAS ALSO A KINK ABOUT 20CM DISTAL TO THE TIP. THE KINKS OCCURRED IN THE PT BUT CAUSED NO PT INJURY AND NO DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F13899

    Patients

    Seq Age Sex Outcome Treatment
    1