BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2151587 · Received June 24, 2011

    Report

    Report Number
    3005168196-2011-00259
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE UNIT RETURNED WITH THE COIL STILL ATTACHED TO THE PUSHER ASSEMBLY, BUT OUTSIDE OF THE INTRODUCER SHEATH. THERE ARE A NUMBER OF KINKS IN THE PROXIMAL END OF THE PUSHER ASSEMBLY. THE INTRODUCER SHEATH WAS THREADED OVER THE PROXIMAL END OF THE ASSEMBLY AND MOVED DISTALLY. THE SHEATH MOVED OVER SOME OF THE KINKS WITH DIFFICULTY BUT WAS ABLE TO REACH THE COIL END. WITH CAREFUL PULLING, THE COIL WAS ABLE TO BE LOADED BACK INTO THE SHEATH. THE PRODUCT IS FULLY FUNCTIONAL. CONCLUSION: THE TECHNICIAN MANIPULATING THE DEVICE ACKNOWLEDGES POSSIBLY MISHANDLING THE DEVICE AND POTENTIALLY DAMAGING IT. THE FUNCTION OF THE COIL DOES NOT AGREE WITH THE COMPLAINT. THERE WAS NO DIFFICULTY LOADING THE COIL INTO THE INTRODUCER SHEATH. THE KINKS IN THE INTRODUCER SHEATH WERE LIKELY DUE TO HANDLING DURING RETURN PACKAGING AND SHIPPING. 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 TECHNOLOGIST COMMENTED THAT THE COIL WAS DIFFICULT TO LOAD THROUGH THE SHEATH. SHE SUGGESTED THAT SHE MAY HAVE MISLOADED THE COIL. THE COIL WAS NOT PLACED IN THE BODY AND AN ALTERNATE COIL OF THE SAME SIZE WAS USED AND SUCCESSFULLY TREATED THE ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F19248

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR