BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 3890990 · Received June 24, 2014

    Report

    Report Number
    3005168196-2014-00417
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 27, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DESCRIPTION HAS BEEN CORRECTED TO INCLUDE "EMBOLIZATION" VS "THROMBECTOMY." CONCLUSION: AFTER FURTHER PROFESSIONAL MEDICAL REVIEW, IT WAS DETERMINED BY THE MANUFACTURER THAT THIS EVENT DOES NOT FALL INTO A "SERIOUS INJURY" CATEGORY. THE MANUFACTURER HAS UPDATED ITS RECORDS TO REFLECT THIS CHANGE. NO FURTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE PRODUCT WAS NOT RETURNED FOR EVALUATION AS THE DEVICE WAS IMPLANTED IN THE PATIENT. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00418 AND 00419. DEVICE WAS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING THE PENUMBRA COIL 400. FOLLOWING A SUCCESSFUL PROCEDURE, AND THE USE OF THREE PENUMBRA COILS, THE PATIENT HAD A HEADACHE THAT THE PHYSICIANS ATTRIBUTED TO AN INFLAMMATORY RESPONSE TO THE COIL MASS AND CLOT WITHIN THE ANEURYSM DOME. THE PHYSICIAN GAVE THE PATIENT A DOSE OF VICODIN AND THE EVENT WAS RESOLVED.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE USING PENUMBRA COIL'S 400. FOLLOWING THE PROCEDURE AFTER USING THREE DIFFERENT PENUMBRA COIL'S 400, THE PATIENT HAD A HEADACHE THAT THE PHYSICIANS ATTRIBUTED TO AN INFLAMMATORY RESPONSE TO THE COIL MASS AND CLOT WITHIN THE ANEURYSM DOME. THE PHYSICIAN GAVE THE PATIENT A DOSE OF VICODIN AND THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367463 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F28815

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other