BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1642423 · Received March 16, 2010

    Report

    Report Number
    3005168196-2010-00349
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Report Date
    July 8, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECH EVAL: THE UNIT WAS FLATTENED ALL ALONG THE 6+CM OF THE DISTAL TIP. IN ADDITION TO BEING OVALIZED, THERE ARE COIL SEPARATIONS (STRETCHING) AT 4.8-4.9 AND 6.5-6.7CM FROM THE DISTAL TIP. CONCLUSION: THE INCIDENT IS CONFIRMED AS REPORTED. POSSIBLE MISHANDLING BY THE PHYSICIAN. THE DHR OF THIS MFG LOT HAS BEEN REVIEWED. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA 02/2010 UPDATE TO THE FDA WARNING LETTER DATED 12/31/2009. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART# 2314-01.A, (LOT# L15336). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. THE DHR REVIEW OF FINAL ASSEMBLY (LOT# L15336) INDICATED THAT INSPECTION OF THE DEVICES RESULTED IN 27 REJECTS FOR VISUAL AND DIMENSIONAL MEASUREMENT. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. ALL PARTS THAT FAILED VISUAL INSPECTION HAVE BEEN REJECTED AND ALL PARTS RELEASED MET SPECIFICATIONS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    THE CATHETER WAS FOUND TO BE CRIMPED ON THE DISTAL END. THE CASE WAS COMPLETED WITH AN ALTERNATE PRODUCT. THE PHYSICIAN BELIEVES THAT HE MAY HAVE CRIMPED THE TIP WHILE PREPARING IT FOR USE OR IT WAS CRIMPED IN THE PACKAGING. THE PHYSICIAN ACKNOWLEDGES THAT HE LIKELY CRIMPED IT AS THE LOCATION OF THE DEFORMITY WOULD HAVE BEEN DIFFICULT IN THE PACKAGING TUBE. THERE IS CONFLICTING INFO ABOUT WHETHER THE DEFORMITY WAS NOTICED BEFORE USE OR AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F15336

    Patients

    Seq Age Sex Outcome Treatment
    1