BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 11927499 · Received June 3, 2021

    Report

    Report Number
    3005168196-2021-01223
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 4, 2021
    Report Date
    July 28, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015507
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS EXPECTED TO BE RETURNED; HOWEVER, ADDITIONAL INFORMATION RECEIVED FROM THE PENUMBRA SALES REPRESENTATIVE INDICATED THAT THE DEVICE WAS LOST IN TRANSIT AND IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, 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. 3005168196-2021-01224; 2. 3005168196-2021-01225; 3. 3005168196-2021-01226; 4. 3005168196-2021-01227. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2021-01224, 3005168196-2021-01225, 3005168196-2021-01226, 3005168196-2021-01227.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH FOUR OTHER SMART COILS; THEREFORE, THE FOUR SMART COILS WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826766 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. 400SMTXSFT0104 F78798 00814548015507

    Patients

    Seq Age Sex Outcome Treatment
    1