BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 15568907 · Received October 10, 2022

    Report

    Report Number
    3013394970-2022-00305
    Event Type
    Injury
    Date Received
    October 10, 2022
    Date of Event
    September 6, 2022
    Report Date
    October 8, 2022
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP NO. 1 TO PROVIDE THE SAMPLE RECEIPT DATE IN SECTION D9 AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. H6: INVESTIGATION FINDINGS : 114 IS BASED UPON THE EVALUATION OF USER FACILITY INFORMATION; 213 IS BASED UPON THE EVALUATION OF THE RETURNED SAMPLE. H6 : INVESTIGATION CONCLUSION : 4310 IS BASED UPON EVALUATION OF THE USER FACILITY INFORMATION; 67 IS BASED UPON THE EVALUATION OF THE RETURNED SAMPLE. ONE (1) 6 FR ANGIOSEAL VIP WAS RETURNED TO TERUMO MEDICAL CORPORATION. THE RETURNED SAMPLE INCLUDED THE CARRIER TUBE, HEMOSTASIS SHEATH. THE DEVICE WAS VISUALLY INSPECTED AND FOUND TO HAVE BEEN IN USED CONDITION WITH VISIBLE SIGNS OF BLOOD. THE HEMOSTASIS SHEATH AND CARRIER TUBE WERE RETURNED FULLY MATED AND IN THE FULLY REAR-LOCKED POSITION. THE CUT WAS IDENTIFIED AT THE DISTAL TIP OF THE DEVICE ASSEMBLY. THE ANCHOR AND COLLAGEN WERE VISIBLE. NO OTHER SIGNS OF DAMAGE OR DEFORMATION TO THE DEVICE WERE IDENTIFIED. FUNCTIONAL TESTING WAS UNABLE TO BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. AN EXACT ROOT CAUSE FOR THE ISSUE WAS UNABLE TO BE DETERMINED. THE DEVICE HISTORY RECORD (DHR) REVIEW DETERMINED THAT THE DEVICE WAS IN A CONFORMING STATE WHEN RELEASED FROM TERUMO CONTROL. THERE IS NO INDICATION THAT ANY MANUFACTURING, DESIGN, OR QUALITY SYSTEM ISSUES MAY HAVE LED TO THIS EVENT. CURRENTLY, NO ACTION IS RECOMMENDED SINCE THIS RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE FAILURE MODE & EFFECTS ANALYSIS (FMEA).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE ANGIO-SEAL DID NOT DEPLOY WITH THE ANCHOR INSIDE THE VESSEL AS INTENDED AND THE WHOLE DEVICE CAME OUT. THE ASSISTING NURSE CUT OPEN THE ANGIO-SEAL SHEATH TO MAKE SURE ALL PARTS WERE STILL LEFT INSIDE THE SHEATH, AND NOTHING WAS LEFT INSIDE THE PATIENT'S VESSEL. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 22 SEPT 2022: THE PROCEDURE BEING PERFORMED WAS A CORONARY ANGIOGRAPHY USING A 6FR SHEATH. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. NO COMPONENTS WERE LEFT IN THE PATIENT, WHICH WAS VERIFIED BY CUTTING THE SHAFT OF THE ANGIO-SEAL DEVICE. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE PATIENT WAS STABLE. NO COMPLICATIONS, THE PATIENT WAS DISCHARGED AFTER TWO HOURS OF BED REST PLUS ONE HOUR OF OBSERVED AMBULATION IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080326 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 0000206812

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention