BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL DETACHMENT HANDLE

    MDR report key: 11304638 · Received February 9, 2021

    Report

    Report Number
    3005168196-2021-00244
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    January 8, 2021
    Report Date
    January 13, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548016139
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND ARE BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT: 3005168196-2021-00244 1. SECTION H. BOX 3. DEVICE RETURNED TO MANUFACTURER? 2. SECTION H. BOX 6. RESULTS CODE 1. 3. SECTION H. BOX 6. CONCLUSIONS CODE 1. 4. SECTION H. BOX 10. ADDITIONAL NARRATIVE AND/OR CORRECTED DATA. THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 1.3005168196-2021-00245.

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED HANDLE REVEALED AN UNDAMAGED, FUNCTIONAL DEVICE. THE HANDLE WAS TESTED ON A TEST FIXTURE AND PERFORMED WITHIN SPECIFICATION. THE NOSE CONE WAS REMOVED FROM THE HANDLE BODY AND WAS MEASURED TO BE WITHIN SPECIFICATION USING PIN GAUGES. THE ROOT CAUSE OF THE DETACHMENT ISSUE DURING THE PROCEDURE COULD NOT BE DETERMINED. PENUMBRA HANDLES ARE 100% VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING INCOMING QUALITY INSPECTION. 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 NUMBER: 3005168196-2021-00245.

    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 NUMBER: 3005168196-2021-00245.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE HANDLE WAS PUT ASIDE AND NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PHYSICIAN THEN USED A NEW HANDLE TO DETACH THE SMART COIL. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198857 PENUMBRA SMART COIL DETACHMENT HANDLE HCG, KRD HCG PENUMBRA, INC. SCH1 F97563 00814548016139

    Patients

    Seq Age Sex Outcome Treatment
    1