BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 2192907 · Received July 25, 2011

    Report

    Report Number
    3005168196-2011-00292
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE UNIT WAS RETURNED IN MULTIPLE PIECES AND INCLUDED THE SHEATH AND THE GUIDE WIRE USED WITH THE UNIT. THE PROXIMAL SECTION OF THE CATHETER HAS INTERNAL STRUCTURAL WIRES EXPOSED AT THE BREAK SITE AND MEASURES 94.5 CM IN LENGTH. THE DISTAL SECTION MEASURES 5.3 CM IN LENGTH AND SHOWS MULTIPLE POINTS OF FLATTENING AND OVALIZATION. APPROXIMATELY 4 CM OF THE DISTAL END OF THE CATHETER IS STRETCHED AND ALL OF THE DISTAL END SUPPORT WIRE IS UNWOUND. THE CATHETER IS NON-FUNCTIONAL. CONCLUSION: THE DAMAGE REPORTED IN THE COMPLAINT IS CONFIRMED. THE CATHETER DISTAL SECTION APPEARS TO HAVE FLATTENED IN ANATOMY AND BECOME JAMMED IN THE FEMORAL SHEATH DURING EXTRACTION. ADDITIONAL FORCE APPLIED TO THE CATHETER TO REMOVE IT FROM THE SHEATH LIKELY LED TO THE BREAK. 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

    WHEN INTRODUCING THE PENUMBRA NEURON DELIVERY CATHETER 070 OVER THE .035 WIRE THROUGH THE SHEATH, THE PHYSICIAN FELT FRICTION WHEN ADVANCING THE NEURON. HE THEN DECIDED TO EXTRACT THE NEURON AND WIRE BACK OUT OF THE SHEATH. IN DOING SO, HE SAID THAT IT APPEARED THAT THE TIP OF THE NEURON HAD BROKEN OFF AND REMAINED IN THE SHEATH. THE WIRE WAS SAID TO LOOK LIKE IT HAD UNRAVELED. THE PHYSICIAN LEFT THE SHEATH IN PLACE AND WENT UP AGAIN WITH ANOTHER NEURON OVER A NEW GUIDE WIRE. THE PATIENT WAS TREATED SUCCESSFULLY. THERE WERE NO PATIENT INJURIES ASSOCIATED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 DQY PENUMBRA, INC. F20600

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR