BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA COIL 400

    MDR report key: 6131917 · Received November 29, 2016

    Report

    Report Number
    3005168196-2016-01727
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 30, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548011905
    PMA / PMN Number
    K120330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2016-01631, 2. 3005168196-2016-01700, 3. 3005168196-2016-01701, 4. 3005168196-2016-01702, 5. 3005168196-2016-01703, 6. 3005168196-2016-01704, 7. 3005168196-2016-01705, 8. 3005168196-2016-01706, 9. 3005168196-2016-01707, 10. 3005168196-2016-01708, 11. 3005168196-2016-01709, 12. 3005168196-2016-01710, 13. 3005168196-2016-01711, 14. 3005168196-2016-01712, 15. 3005168196-2016-01713, 16. 3005168196-2016-01714, 17. 3005168196-2016-01715, 18. 3005168196-2016-01716, 19. 3005168196-2016-01717, 20. 3005168196-2016-01718, 21. 3005168196-2016-01719, 22. 3005168196-2016-01720, 23. 3005168196-2016-01721, 24. 3005168196-2016-01722, 25. 3005168196-2016-01723, 26. 3005168196-2016-01724, 27. 3005168196-2016-01725, 28. 3005168196-2016-01726. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THE DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE LEFT INTERNAL CAROTID ARTERY (ICA) PROCEDURE USING PENUMBRA COIL 400S (PC400). DURING THE PROCEDURE, WHILE ADVANCING THE 28TH PC400 THROUGH THE PX SLIM DELIVERY CATHETER (PX SLIM) THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THE PHYSICIAN THEN REMOVED THE PX SLIM IN ORDER TO REMOVE THE DETACHED PC400. THE PROCEDURE WAS COMPLETED USING THE SAME PX SLIM AND A NEW PC400. AFTER THE PROCEDURE, THE PATIENT¿S CONDITION WORSENED AND A COMPUTERIZED TOMOGRAPHY (CT) CONFIRMED THAT THE PATIENT SUFFERED A SUBARACHNOID HEMORRHAGE (SAH) WHICH WAS BELIEVED TO BE FROM THE ANEURYSM. IT IS UNKNOWN WHAT CAUSED THIS SAH. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO EMBOLIZE THE PARENT VESSEL USING NON-PENUMBRA COILS IN ORDER TO TREAT THIS SAH; THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT¿S CONDITION WAS STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783664 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F69348 00814548011905

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention