BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 17762254 · Received September 17, 2023

    Report

    Report Number
    3013394970-2023-00429
    Event Type
    Malfunction
    Date Received
    September 17, 2023
    Date of Event
    August 18, 2023
    Report Date
    September 17, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 6FR ANGIO-SEAL DEVICE WAS RETURNED FOR PRODUCT EVALUATION. THE RETURNED DEVICE INCLUDED THE CARRIER TUBE AND 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 FULLY REAR LOCKED. THE SUTURE WAS NOT VISIBLE, AND THE CARRIER TUBE HUB WAS OPENED TO FURTHER INSPECT THE INTERNAL CONTENTS. HOWEVER, THE SUTURE WAS NOT PRESENT WITHIN THE HUB. NO OTHER DAMAGE OR ISSUES WERE IDENTIFIED. THE COMPLAINT WAS CONFIRMED FOR A POTENTIAL SUTURE BREAKAGE/DETACHMENT. THE EXACT ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE LIKELY CAUSE WAS DETERMINED TO HAVE BEEN RETRACTING THE DEVICE WITH EXCESSIVE FORCE/SPEED CAUSING SUTURE BREAKAGE TO OCCUR. AN INVESTIGATION WAS PERFORMED BY THE MANUFACTURING FACILITY; HOWEVER, NO ISSUE ATTRIBUTABLE TO THE MANUFACTURING PROCESS WAS IDENTIFIED. 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 AND EFFECTS ANALYSIS (FMEA)/HAZARD BASED RISK TABLE (HBRT).

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT AVAILABLE DUE TO NHS RULES. A2: AGE & DATE OF BIRTH: REQUESTED, NOT AVAILABLE DUE TO NHS RULES. A3: PATIENT SEX: REQUESTED, NOT AVAILABLE DUE TO NHS RULES. A4: WEIGHT: REQUESTED, NOT AVAILABLE DUE TO NHS RULES. A5: ETHNICITY: REQUESTED, NOT AVAILABLE DUE TO NHS RULES. A6: RACE: REQUESTED, NOT AVAILABLE DUE TO NHS RULES. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: SUPERINTENDENT RADIOGRAPHER. 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 THEY HAD A 6FR ANGIOGRAM - CORONARY STUDY. THERE WERE NO DIFFICULTIES WITH THE CASE OR WITH THE ANGIO-SEAL DEPLOYMENT UNTIL THE SUTURE SNAPPED JUST BELOW THE WHITE MARKER AS NORMAL TENSION WAS APPLIED TO DEPLOY THE DEVICE. CONSULTANT, WHO IS AN EXPERIENCED USER, WAS ABLE TO GRAB THE REMAINING SUTURE AND COMPLETE THE ANGIO-SEAL DEPLOYMENT. THERE WAS NO BLOOD LOSS. THE ANGIO-SEAL WAS SUCCESSFUL, AND THE PATIENT WAS DISCHARGED AS PLANNED. THERE ARE NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 25AUG2023: THE PATIENT WAS IN STABLE CONDITION AND WAS DISCHARGED ON SCHEDULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299872 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 0000335911

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown