BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 5336917 · Received December 30, 2015

    Report

    Report Number
    3005168196-2015-01368
    Event Type
    Malfunction
    Date Received
    December 30, 2015
    Date of Event
    December 3, 2015
    Report Date
    December 3, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015231
    PMA / PMN Number
    K151572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2015-01365, 2. 3005168196-2015-01366, 3. 3005168196-2015-01367. THE DEVICE WAS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE PARAOPTHALMIC ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED SIX SMART COILS USING THE HANDLE. HOWEVER, THE PHYSICIAN HAD DIFFICULTY DETACHING THE NEXT THREE NEW SMART COILS USING THE HANDLE BUT THEY EVENTUALLY DETACHED. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859478 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. F66303 00814548015231

    Patients

    Seq Age Sex Outcome Treatment
    1