BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE,OUS

    MDR report key: 17140898 · Received June 16, 2023

    Report

    Report Number
    3013394970-2023-00240
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 12, 2023
    Report Date
    June 15, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION D9, SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. ONE (1) 6FR ANGIO-SEAL DEVICE WAS RETURNED FOR PRODUCT EVALUATION. THE RETURNED DEVICE INCLUDED THE LOCATOR, HEMOSTASIS SHEATH, AND HEADER BAG. THE DEVICE WAS VISUALLY INSPECTED AND FOUND TO HAVE BEEN IN USED CONDITION. FUNCTIONAL TESTING WAS PERFORMED BY ATTEMPTING TO CONNECT AND DISCONNECT THE LOCATOR AND HEMOSTASIS SHEATH. THE COMPONENTS WERE CONNECTED AND DISCONNECTED MULTIPLE TIMES, AND MINOR AUDITORY AND TACTILE FEEDBACK WERE DETECTED. HOWEVER, COMPONENT CONNECTION APPEARED TO HAVE BEEN IMPAIRED AS COMPONENT SEPARATION WAS ABLE TO BE ACHIEVED WITH MINIMAL FORCE. THE COMPLAINT WAS ABLE TO BE CONFIRMED FOR A SHEATH AND LOCATOR CONNECTION ISSUE. NCR WAS COMPLETED BY THE MANUFACTURING FACILITY, AND THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO HAVE BEEN A MACHINE REPAIR WHICH OCCURRED ON 10/05/2022 AFFECTING PART INTERFERENCE BETWEEN THE HUB AND THE CAP. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS GENERATED IN RESPONSE TO THE ISSUE TO CREATE CORRECTIVE AND PREVENTIVE ACTIONS, ANDDDITIONAL INFORMATION CONCERNING THE RESULTS OF THE CAPA WILL BE CAPTURED IN THE CAPA DOCUMENT. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO MANUFACTURING ISSUE WAS IDENTIFIED WITHIN THE DOCUMENTATION.

    Additional Manufacturer Narrative · 0

    D6B: 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.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE INCIDENT HAPPENED DURING THE STEP "SET THE ANCHOR" AFTER A TACE INTERVENTION WITH A 6F IK. THE PHYSICIAN INSERTED THE INVOLVED ANGIO-SEAL DEVICE INTO THE SHEATH, FIRST CLICK AND SECOND CLICK TO SET THE ANCHOR. DURING THIS PROCEDURE HE WAS NOT ABLE TO PULL BACK THE ANGIO-SEAL OVER THE TWO FINAL CLICKS. HE GRABBED THE SUTURE MANUALLY AND WAS ABLE TO PULL BACK THE DEVICE UNTIL THE SUTURE STOPS. HE PUSHED DOWN THE TUBE UNTIL REACHING THE BLACK MARKER, CONFIRMED HEMOSTASIS, AND CUT THE SUTURE. THERE WAS NO BLEEDING OR HEMATOMA AFTER THE INTERVENTION MENTIONED. ADDITIONAL INFORMATION WAS RECEIVED ON 05 JUNE 2023: THE PROCEDURE THAT WAS BEING PERFORMED FOR THE PATIENT PRIOR TO THE CLOSURE DEVICE USED WAS A TACE INTERVENTION. PROCEDURE SHEATH SIZE USED WAS 6FR. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THE ISSUES WERE WITH THE DEPLOYMENT. HEMOSTASIS WAS ACHIEVED WITH THE ANGIO-SEAL DEVICE ONLY. ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551641 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE,OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 0000307229

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown