BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 12701115 · Received October 26, 2021

    Report

    Report Number
    3005168196-2021-02398
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    September 28, 2021
    Report Date
    February 1, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015781
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION IS BEING UPDATED BASED ON ADDITIONAL INFORMATION PROVIDED BY A PENUMBRA SALES REPRESENTATIVE ON 27-JAN-2022: 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM BASED ON ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT THERE WAS NO ALLEGATION ON THIS DEVICE. IT WAS INITIALLY UNDERSTOOD THAT TWELVE DEVICES WERE INVOLVED WITH THE CASE. HOWEVER, ADDITIONAL CLARIFICATION INDICATED THAT ONLY NINE DEVICES WERE RELATED TO THE CASE. THIS DEVICE IS NOT COMPLAINT RELATED AND, THEREFORE, NOT A REPORTABLE EVENT. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2021-02388; 2. 3005168196-2021-02389; 3. 3005168196-2021-02390; 4. 3005168196-2021-02391; 5. 3005168196-2021-02392; 6. 3005168196-2021-02393; 7. 3005168196-2021-02394; 8. 3005168196-2021-02396; 9. 3005168196-2021-02399; 10. 3005168196-2021-02401; 11. 3005168196-2021-02402. H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A 5F DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH FIVE OTHER SMART COILS. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS WITH THREE DIFFERENT HANDLES. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA MICROCATHETER, A 5F DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH EIGHT OTHER SMART COILS. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS WITH THREE DIFFERENT HANDLES. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597864 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. 400SMTHXSFT0306 C22069 00814548015781

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown