BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 11898380 · Received May 27, 2021

    Report

    Report Number
    3005168196-2021-01174
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    April 27, 2021
    Report Date
    July 24, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015101
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION IS BEING UPDATED BASED ON ADDITIONAL INFORMATION PROVIDED BY THE PENUMBRA CLINICAL TEAM ON 01-JULY-2021: 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. 2. SECTION G. BOX 3. REPORT SOURCE. IT WAS PREVIOUSLY UNDERSTOOD THAT THERE WERE FOUR SMART COILS THAT WOULD NOT ADVANCE OR RESISTANCE WAS EXPERIENCED WHILE RE-SHEATHING. HOWEVER, BASED ON THE ADDITIONAL INFORMATION, THERE WERE ONLY THREE SMART COILS THAT HAD THIS ISSUE, NOT FOUR. THERE WAS NO ALLEGATION AGAINST A FOURTH SMART COIL. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2021-01171; 2. 3005168196-2021-01172; 3. 3005168196-2021-01173. H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. 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 ANOTHER SMART COIL. THEREFORE, THE SMART COIL WAS ALSO REMOVED. IT WAS REPORTED THAT THE INTRODUCER SHEATHS OF THE SMART COILS SEPARATED AROUND THE FRICTION LOCK WHEN FORCE WAS USED. THEN, WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH THE SMART COIL. WHILE RE-SHEATHING THE SMART COIL, RESISTANCE WAS ENCOUNTERED, AND SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE SMART COIL BECAME BENT. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NINE SMART COILS, THREE NON-PENUMBRA COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    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: 3005168196-2021-01171. 3005168196-2021-01172. 3005168196-2021-01173.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. 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 ANOTHER SMART COIL. THEREFORE, THE SMART COIL WAS ALSO REMOVED. IT WAS REPORTED THAT THE INTRODUCER SHEATHS OF THE SMART COILS SEPARATED AROUND THE FRICTION LOCK WHEN FORCE WAS USED. THEN, WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH THE SMART COIL. WHILE RE-SHEATHING THE SMART COIL, RESISTANCE WAS ENCOUNTERED, AND SUBSEQUENTLY, THE PHYSICIAN BENT THE PUSHER ASSEMBLY OF THE SMART COIL. THEREFORE, THE SMART COIL WAS REMOVED. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, IT WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NINE SMART COILS, THREE NON-PENUMBRA COILS, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789943 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. 400SMTSFT0510 F98291 00814548015101

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR