BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 21998241 · Received May 9, 2025

    Report

    Report Number
    3013394970-2025-00223
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    April 9, 2025
    Report Date
    May 9, 2025
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011820
    PMA / PMN Number
    00011P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. ONE (1) 6 FR ANGIO-SEAL VIP DEVICE WAS RETURNED. THE RETURNED SAMPLE INCLUDES THE GUIDEWIRE, HEMOSTASIS SHEATH, CARRIER TUBE, ARTERIOTOMY LOCATOR AND HEADER BAG. THE DEVICE WAS SUBJECTED TO VISUAL AND FUNCTIONAL ANALYSIS. THE DEVICE APPEARS TO BE IN USED CONDITION, WITH VISIBLE SIGNS OF BLOOD. THE HEMOSTASIS SHEATH AND CARRIER TUBE WERE FULLY MATED, IN REAR LOCK POSITION. THE ANCHOR WAS EXPOSED AT THE DISTAL TIP. THE ANCHOR WAS MANUALLY PULLED. THE ANCHOR, COLLAGEN AND TAMPER TUBE FULLY DEPLOYED. THE COMPLAINT CAN BE CONFIRMED FOR A NON-DEPLOYMENT DEVICE PULLOUT. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. THE LIKELY CAUSE IS THERE WAS AN OBSTRUCTION AT THE SHEATH TIP, PREVENTING THE ANCHOR FROM DEPLOYING AND POSTING. THE DEVICE HISTORY RECORD REVIEW DETERMINED 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 HAZARD BASED RISK TABLE (HBRT).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS PERFORMING A GENICULAR ARTERY EMBOLIZATION (GAE) PROCEDURE VIA CONTRALATERAL APPROACH WITH A 6 FRENCH (FR) X 45-CENTIMETER (CM) DESTINATION SHEATH. PRIOR TO CLOSURE, A FEMORAL ANGIOGRAM WAS PERFORMED. THE ANGIOGRAM SHOWED NO SIGNIFICANT ATHEROSCLEROSIS; THE VESSEL MEASURED 6 MILLIMETERS (MM) AND THE ARTERIOTOMY WAS IN THE COMMON FEMORAL ARTERY. THE ANGIO-SEAL SHEATH AND DILATOR WERE INTRODUCED OVER THE WIRE, AND THERE WAS NO ISSUE IN EITHER GETTING THE INITIAL ACCESS, NOR IN INTRODUCING THE ANGIO-SEAL SYSTEM. WHEN THE PHYSICIAN CONNECTED THE ANGIO-SEAL SHEATH AND DEVICE, SET THE ANCHOR, AND PULLED BACK ON THE DEVICE, THE ENTIRE ANGIO-SEAL DEVICE CAME OUT OF THE PATIENT. THE PHYSICIAN COULD SEE PART OF THE ANGIO-SEAL ANCHOR STICKING OUT OF THE END OF THE ANGIO-SEAL SHEATH AND PULLED IT OUT TO CONFIRM THAT THE ENTIRE ANCHOR WAS INTACT AND NOT IN THE PATIENT. THE DEVICE WAS INTACT. MANUAL PRESSURE WAS HELD TO OBTAIN HEMOSTASIS AT THE ACCESS SITE. THE PATIENT REMAINED STABLE THROUGHOUT AND THE PROCEDURE WAS A SUCCESS. NO INTERVENTION WAS NEEDED. BLOOD LOSS WAS LESS THAN 250 CC. PROCEDURE TYPE PERFORMED WAS A GENICULAR ARTERY EMBOLIZATION (GAE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969195 ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION 610132 0000755651 00389701011820

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female