BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 6772563 · Received August 7, 2017

    Report

    Report Number
    3005168196-2017-01332
    Event Type
    Malfunction
    Date Received
    August 7, 2017
    Date of Event
    July 10, 2017
    Report Date
    July 11, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015262
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2017-01332. 1. SECTION H. BOX 4. DEVICE MANUFACTURE DATE. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2017-01331, AND 2. 3005168196-2017-01333. H3 OTHER TEXT : PLACEHOLDER.

    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: 3005168196-2017-01331, 3005168196-2017-01333. THE DEVICE WAS IMPLANTED INTO THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN MADE ONE ATTEMPT TO DETACH THE FIRST AND THIRD SMART COILS USING THE HANDLE BUT WAS UNSUCCESSFUL. A SECOND ATTEMPT WAS MADE USING THE SAME HANDLE AND BOTH SMART COILS WERE SUCCESSFULLY DETACHED. THE PROCEDURE WAS COMPLETED AFTER DETACHING THE THIRD COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552536 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. 400SMTXSFT0202 F72585 00814548015262

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR