BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL

    MDR report key: 13578617 · Received February 22, 2022

    Report

    Report Number
    3005168196-2022-00074
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    April 1, 2019
    Report Date
    February 22, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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 27-JAN-2022, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "MIGRATION OF NONFIBERED PACKING COILS USED TO TREAT PERIPHERAL PSEUDOANEURYSMS: REPORT OF 3 CASES" (GONZALEZ-ARAIZA ET AL. 2019). THIS ARTICLE REPORTS THREE CASES OF PENUMBRA COIL MIGRATION INTO THE LUMENS OF ADJACENT VISCERA: TWO INTO THE DUODENUM AND ONE INTO THE VAGINA. IN THE THIRD CASE STUDY, THE PHYSICIAN USED RUBY COILS AND POD PCS TO EMBOLIZE THE LEFT UTERINE ARTERY. APPROXIMATELY ONE MONTH AFTER EMBOLIZATION, THE PATIENT REPORTED SPONTANEOUS VAGINAL PASSAGE OF A PENUMBRA COIL (UNKNOWN). SHE REMOVED THE COIL AND EXPERIENCED SOME LIGHT SPOTTING, WHICH RESOLVED SPONTANEOUSLY. THE PATIENT HAS BEEN ASYMPTOMATIC FOR 6 MONTHS. 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
    161442 PENUMBRA COIL HCG PENUMBRA, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female