BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1760847 · Received July 14, 2010

    Report

    Report Number
    3005168196-2010-00529
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 16, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: A FEMORAL SHEATH WAS RETURNED WITH 1.5 CM OF THE DISTAL TIP OF THE CATHETER HANGING FROM THE DISTAL END OF THE SHEATH. THE VISIBLE SECTION WAS OVALIZED AND JAMMED IN PLACE. A 0.070" MANDREL WAS INTRODUCED INTO THE PROXIMAL END OF THE SHEATH AND PRESSED OUT THE BROKEN DISTAL END OF THE CATHETER. THE DISTAL TIP OF THIS FRAGMENT SHOWS OVALIZATION OVER THE ENTIRE LENGTH WITH THE MOST PRONOUNCED SECTION EXTENDING FROM 4.7 TO 6.5 CM FROM THE DISTAL TIP THAT SHOWS EXPANSION TO 175% OF NORMAL. THIS SECTION ALSO SHOWS EVIDENCE OF COMPRESSION DAMAGE. THERE IS A SINGLE AXIS BEND 1.0 CM FROM THE DISTAL TIP. THE MEASURED LENGTH OF THE DISTAL SECTION IS 10.5 CM. AS A RESULT OF THE FRACTURE, THE CATHETER IS NON-FUNCTIONAL. CONCLUSION: THE DISTAL SECTION OF THE CATHETER APPEARS TO HAVE BECOME JAMMED IN THE SHEATH AS THE RESULT OF OVALIZING IN TORTUOUS ANATOMY. IT IS UNCLEAR IF THE STRETCHING AND COMPRESSION DAMAGE OCCURRED DEEPER INSIDE THE PATIENT OR IF THEY OCCURRED IN THE SHEATH ALONE. THE DHR OF THIS MANUFACTURING LOT HAS BEEN REVIEWED. THE REVIEW REVEALED THAT ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION. ALL PARTS THAT WERE RELEASED IN THIS LOT MET SPECIFICATIONS.

    Description of Event or Problem · 1

    A NEURON 070 WAS USED AS THE ACCESS CATHETER FOR A BASILAR STENTING PROCEDURE. FOUR NEUROFORM STENTS WERE DELIVERED DURING THE DURATION OF THE CASE. THE ANATOMY PRESENTED WITH SOME TORTUOSITY (180 DEGREE BEND) WHICH THE NEURON NAVIGATED WELL. THE OPERATING PHYSICIAN FELT THERE MIGHT HAVE BEEN SOME SLIGHT KINKING OF THE NEURON AT OR NEAR THE BEND. THE STENTS WERE DELIVERED WITHOUT INCIDENT. UPON THE COMPLETION OF THE CASE, THEY PLANNED ON WITHDRAWING THE NEURON TO DO A FINAL RUN THROUGH THE SHEATH IN THE FEMORAL ARTERY. WHEN THEY WITHDREW THE NEURON THROUGH THE SHEATH THEY NOTICED THAT THE END PORTION PULLED OUT OF THE SHEATH HAD STAINLESS STEEL COILING COMING UNDONE OF THE DISTAL END OF THE WITHDRAWN PORTION. UPON FURTHER EXAMINATION THEY DETERMINED A PORTION OF THE DISTAL NEURON HAD BROKEN OFF. AT THIS POINT THEY WITHDREW THE SHEATH IN THE FEMORAL ARTERY AND DISCOVERED THE BROKEN DISTAL PORTION OF THE NEURON STILL LODGED AND PROTRUDING OUT OF THE DISTAL END OF THE SHEATH. THEY DID NOT USE A CLOSURE DEVICE BECAUSE OF THE INCIDENT AND USED MANUAL PRESSURE ON THE FEMORAL EXCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F16915

    Patients

    Seq Age Sex Outcome Treatment
    1