BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US

    MDR report key: 12494751 · Received September 20, 2021

    Report

    Report Number
    3013394970-2021-00526
    Event Type
    Injury
    Date Received
    September 20, 2021
    Date of Event
    August 2, 2021
    Report Date
    September 20, 2021
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011820
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE DEVICE RETURN DATE IN SECTION D9, TO UPDATE SECTION H3. TO UPDATE SECTIONS E4 AND G2, AND TO PROVIDE THE MAUDE REPORT 1232382 WITHIN THE FILE ATTACHMENTS. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ONE 6 FR ANGIO-SEAL VIP WAS RETURNED. THE RETURNED SAMPLE INCLUDED THE HEMOSTASIS SHEATH, CARRIER TUBE, AND LOCATOR. VISUAL INSPECTION REVEALED THAT THE HEMOSTASIS SHEATH AND CARRIER TUBE WERE CONNECTED AND RETURNED IN THE FULLY REAR-LOCKED POSITION. THE DISTAL TIP OF THE SHEATH AND CARRIER TUBE HAD BEEN CUT OPEN, AND THE SHEATH HAD BEEN SEPARATED FROM THE CARRIER TUBE. THE ANCHOR, SUTURE, AND COLLAGEN WERE EXPOSED AND HANGING OUTSIDE OF THE CARRIER TUBE. THE LOCATOR WAS ALSO RETURNED, BUT NO SIGNS OF DAMAGE OR DEFORMATION ON IT WERE IDENTIFIED. FUNCTIONAL TESTING WAS UNABLE TO BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE COMPLAINT CAN BE CONFIRMED FOR NON-DEPLOYMENT DEVICE PULLOUT. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. THE LIKELY CAUSE IS AN OBSTRUCTION TO THE ANCHOR POSTING TO THE TIP OF THE HEMOSTASIS SHEATH. FUNCTIONAL TESTING WAS UNABLE TO BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE DHR REVIEW DETERMINED THAT THE DEVICE WAS IN A CONFORMING STATE WHEN RELEASED FROM TERUMO CONTROL. THERE IS NO INDICATION THAT ANY MANUFACTURING ISSUES MAY HAVE LED TO THIS EVENT. CURRENTLY, NO ACTION IS RECOMMENDED SINCE THIS RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE FMEA.

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS.

    Description of Event or Problem · 1

    TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "THIS IS A COLLAGEN PLUG THAT IS PLACED IN THE ARTERY POST ARTERIOGRAM. WHEN THE PHYSICIAN WENT TO INJECT IT IN IT WAS NOT THERE. AFTER USING FLUOROSCOPY TO MAKE SURE IT WAS NOT IN PATIENT, HE JUST PULLED THE SHEATH AND HELD PRESSURE FOR HEMOSTASIS. AFTER THAT HE BASICALLY DISSECTED THE CLOSURE DEVICE AND FOUND THE COLLAGEN PLUG WAS HALFWAY BACK IN SHAFT OF INTRODUCER." THE ORIGINAL INTENDED PROCEDURE WAS: "CARDIAC CATHERIZATION: DIAGNOSTIC LEFT AND RIGHT HEART CATH TO EVALUATE EPICARDIAL CORONARIES, VALVE STENOSIS AS WELL AS RIGHT SIDED PRESSURES" ADDITIONAL INFORMATION WAS RECEIVED ON 27AUG2021. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1394719 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 0000043028 00389701011820

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention