BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 14581316 · Received June 2, 2022

    Report

    Report Number
    3005168196-2022-00253
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    January 1, 2012
    Report Date
    June 2, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 0

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON 09-MAY-2022, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "THE EFFECTIVENESS OF PENUMBRA 400 MICRO-COILS IN THE EMBOLIZATION OF LARGE CEREBRAL ANEURYSMS" (POPIELA ET AL. 2017). IN THIS RETROSPECTIVE REVIEW, THIRTY-TWO PATIENTS WITH LARGE CEREBRAL ANEURYSMS WERE TREATED WITH PENUMBRA COIL 400S (PC400S) DELIVERED WITH A PX SLIM DELIVERY MICROCATHETER (PX SLIM) BETWEEN 01-JAN-2012 AND 01-JUN-2015. IN ONE CASE, THE TERMINAL LOOP OF THE PC400 MIGRATED FROM THE ANEURYSM SAC INTO THE PARENT VESSEL. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE, NOR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, THIS REPORT ADDRESSES ALL MALFUNCTIONS AND/OR ADVERSE EVENTS WITHIN THIS LITERATURE SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977497 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown