BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 20698910 · Received November 15, 2024

    Report

    Report Number
    3013394970-2024-00628
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    October 8, 2024
    Report Date
    November 15, 2024
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011806
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: MANAGER CIG DEAKIN & ANGIOGRAPHY SUITE. THE ACTUAL DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. SINCE THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION, THE COMPLAINT CANNOT BE CONFIRMED. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. IT IS LIKELY THAT A NON-DEPLOYMENT EVENT OCCURRED DUE TO AN OBSTRUCTION OF THE DISTAL TIP. 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).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE CLINICIAN DEPLOYED THE ANGIO-SEAL DEVICE OVER THE WIRE INTO THE COMMON FEMORAL ARTERY. (CFA) WITHOUT ISSUE; HOWEVER, UPON PULL BACK, THE WHOLE DEVICE CAME OUT OF THE GROIN, AND MANUAL COMPRESSION WAS APPLIED. THE NURSE NOTED THAT THE ANCHOR WAS STILL IN THE TIP OF THE SHEATH. ADDITIONAL INFORMATION WAS RECEIVED ON 27OCT2024: THE PATIENT PROCEDURE IS UNKNOWN. A 6FR PROCEDURE SHEATH USED. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. ULTRASOUND WAS USED FOR THE CASE. THE PATIENT CONDITION WAS STABLE. THERE WAS NO BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323447 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION 610132 0000513574 00389701011806

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention