BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 2181122 · Received July 8, 2011

    Report

    Report Number
    3005168196-2011-00276
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 15, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE CATHETER SHOWED MULTIPLE FLAT SPOTS ATTRIBUTABLE TO POST COMPLAINT HANDLING DAMAGE. THERE IS A FLAT SPOT THAT IS NOT ATTRIBUTABLE TO POST COMPLAINT HANDLING BETWEEN 8.7 AND 9.5 CM FROM THE DISTAL TIP. THE FLATTENING SEEN FROM THE TIP TO 2.8 CM AND THE FLAT SPOTS CENTERED AT 4.9 AND 5.7 CM FROM THE TIP ARE ALL IN THE SAME PLANE AND CONSISTENT WITH HANDLING/RETURN SHIPPING DAMAGE. A 0.070" MANDREL WAS INTRODUCED INTO THE HUB AND ADVANCED DISTALLY. THE MANDREL STOPPED AT THE FIRST OF THE HANDLING INDUCED FLAT SPOTS, APPROX 14 CM FROM THE HUB. THE DISTAL TIP OF THE CATHETER WAS INTRODUCED INTO A DEMONSTRATION SHIPPING TUBE. THE FLATTENING OF THE TIP PREVENTED PROPER INTRODUCTION INTO THE TUBE. THE CATHETER IS NON-FUNCTIONAL. CONCLUSION: THE FLAT SPOT BETWEEN 8.7 AND 9.5 CM FROM THE TIP IS CONSISTENT WITH THE DAMAGE REPORTED IN THE COMPLAINT. THE WIDTH OF THIS FLAT SPOT IS GREATER THAN THE WIDTH OF THE FLATTENED TIP AND THE HANDLING DAMAGE. SINCE THESE FLAT SECTIONS WOULD NOT FIT INTO THE SHIPPING TUBE, THE DAMAGE TO THE CATHETER PROBABLY HAPPENED AFTER ITS REMOVAL FROM THE PACKAGING. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE TECHNIQUE TOOK THE NEURON DELIVERY CATHETER 070 OUT OF THE PACKAGE AND THE TIP WAS KINKED. THE TECHNICIAN OPENED A SECOND ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 DQY PENUMBRA, INC. F20265

    Patients

    Seq Age Sex Outcome Treatment
    1