BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 2093336 · Received April 19, 2011

    Report

    Report Number
    3005168196-2011-00148
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 22, 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

    THE CATHETER IS BROKEN 86.5 CM FROM THE END OF THE STRAIN RELIEF HYPOTUBE. ACCORDING TO THE DRAWING FOR THIS PART THAT MEANS APPROXIMATELY 8.5 CM OF THE CATHETER BROKE OFF INSIDE THE SHEATH. THERE IS AN OVALIZATION ON THE MOST DISTAL 2.5 CM OF THE REMAINING CATHETER. A 0.070" MANDREL WAS INTRODUCED INTO THE HUB AND ADVANCED DISTALLY. APPROXIMATELY 2 CM FROM THE DISTAL TIP OF THE RETURNED PIECE, THE MANDREL STOPPED. THE CATHETER IS NON-FUNCTIONAL. CONCLUSION: THE OVALIZATION OF THE TIP OF THE RETURNED CATHETER IMPLIES THAT THERE MAY HAVE BEEN AN OVALIZATION IN THE BROKEN SECTION. THIS IS LIKELY WHAT CAUSED THE CATHETER TO GET STUCK IN THE FEMORAL SHEATH. THE FRACTURE OCCURRED WHEN THE PHYSICIAN WAS REMOVING THE CATHETER AT THE END OF THE CASE. IT IS COMMON FOR THE CATHETER TIP TO OVALIZE SLIGHTLY IN ANATOMY DURING USE. ONCE THE CATHETER WAS STUCK, IT LIKELY TOOK EXCESS FORCE TO REMOVE IT FROM THE SHEATH CAUSING THE FRACTURE. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING A PENUMBRA NEURON DELIVERY CATHETER 070 WITH A PINNACLE SHEATH ((B)(4)). WHEN THE PHYSICIAN REMOVED THE NEURON FROM THE SHEATH AT THE END OF THE CASE, THE FLEXIBLE TIP OF THE NEURON BECAME HUNG UP ON THE END OF THE SHEATH AND BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 DQY PENUMBRA, INC. F19254

    Patients

    Seq Age Sex Outcome Treatment
    1