BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 6772512 · Received August 7, 2017

    Report

    Report Number
    3005168196-2017-01348
    Event Type
    Malfunction
    Date Received
    August 7, 2017
    Date of Event
    July 3, 2017
    Report Date
    July 13, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE MANUFACTURER COULD NOT DETERMINE WHICH OF THE FOLLOWING LOT NUMBERS CORRESPONDED TO THE PENUMBRA SMART COILS IN COMPLAINT: F71871, MANUFACTURE DATE: 10/03/2016, EXPIRATION DATE: 10/02/2021, F73016, MANUFACTURE DATE: 12/05/2016, EXPIRATION DATE: 12/04/2021, F72478, MANUFACTURE DATE: 10/25/2016, EXPIRATION DATE: 10/24/2021. 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 THE LOT NUMBERS ABOVE WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2017-001347, 3005168196-2017-001349. THE HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OCCIPITAL ARTERY TO TREAT A DURAL ARTERIOVENOUS FISTULA (D-AVF) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED TWO SMART COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER BUT HAD DIFFICULTY DETACHING THE COILS WITH THE HANDLE. IT WAS REPORTED THAT THE ONE OF THE SMART COILS WAS DETACHED AFTER THREE ATTEMPTS AND THE OTHER SMART COIL WAS DETACHED AFTER THE SECOND ATTEMPT. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, TWO NEW SMART COILS AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552272 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1