BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US

    MDR report key: 19102584 · Received April 13, 2024

    Report

    Report Number
    3013394970-2024-00145
    Event Type
    Injury
    Date Received
    April 13, 2024
    Date of Event
    March 12, 2024
    Report Date
    April 12, 2024
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011820
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A3B: GENDER: N/A. A4: WEIGHT: REQUESTED, NOT PROVIDED. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: INTERVENTIONAL RADIOLOGIST. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ONE (1) 6FR ANGIO-SEAL DEVICE WAS RETURNED FOR PRODUCT EVALUATION. THE RETURNED DEVICE INCLUDED THE HEMOSTASIS SHEATH, ARTERIOTOMY LOCATOR AND HEADER BAG. THE DEVICE WAS VISUALLY INSPECTED AND FOUND TO HAVE BEEN IN USED CONDITION WITH VISIBLE SIGNS OF BLOOD. THE SHEATH AND LOCATOR ASSEMBLY WERE FOUND WITH A KINK AT THE BLOOD INLET HOLES. NO OTHER DAMAGE OR ISSUES WERE FOUND. THE COMPLAINT CAN BE CONFIRMED FOR SHEATH/LOCATOR MECHANICAL DAMAGE. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE LIKELY CAUSE WAS DETERMINED TO HAVE BEEN DAMAGE SUSTAINED TO THE ASSEMBLY DUE TO OFF AXIS LOADING OF THE DURING INSERTION. 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 INVOLVED ANGIO-SEAL DEVICE WAS USED AFTER THE DOCTOR COMPLETED A Y90 TREATMENT PROCEDURE. THE ANGIO-SEAL ARTERIOTOMY LOCATOR WAS KINKING IN THE SHEATH. AT THE END OF THE PROCEDURE POST Y90 DELIVERY THROUGH A 2.4 PROGREAT MICROCATH SYSTEM. ACCESS WAS AT THE LEFT COMMON FEMORAL ARTERY WITH A 6FR BRITE-TIP CORDIS SHEATH. A 5FR GUIDE CATH WAS IN THE DESCENDING AORTA WHEN THE DOCTOR REMOVED THE PROGREAT. THE DOCTOR THEN PUT A BENTSON WIRE INTO THE GUIDE CATH AND REMOVED IT. THE SCRUB TECH AT THE TABLE RECEIVED THE 6FR ANGIO-SEAL DEVICE AND PUT THE ARTERIOTOMY LOCATOR INTO THE SHEATH WITH THE ARROWS LINED UP. ALL CONTENTS OF THE ANGIO-SEAL PACKAGE WERE THEN TRANSFERRED ONTO THE BLUE DRAPE ON THE PATIENT. THE DOCTOR THEN LEFT THE BENTSON WIRE IN THE AORTA AND REMOVED THE 6FR PROCEDURE SHEATH. HE LOADED THE ARTERIOTOMY LOCATOR ONTO THE BENTSON WIRE AND CONTINUED TO ADVANCE INTO THE PATIENT. UPON ADVANCING THE ENTIRE SYSTEM KINKED AT THE INLET HOLES. THE SYSTEM THEN BECAME STUCK IN THE PATIENT AND THE DOCTOR ATTEMPTED TO REMOVE IT. WHICH CAUSED THE BENTSON WIRE TO COME BACK WITH THE ANGIO-SEAL SHEATH. ONCE THE SHEATH WAS OUT OF THE PATIENT A NOTICEABLE KINK WAS SEEN AND THE DOCTOR DID NOT FEEL COMFORTABLE ATTEMPTING IT AGAIN WITH A DIFFERENT ANGIO-SEAL AS THE WIRE ACCESS WAS NOT STABLE. MANUAL PRESSURE WAS THEN DECIDED TO BE THE BEST OPTION. ESTIMATED BLOOD LOSS WAS 3 ML. THERE WAS NO HARM TO THE PATIENT. NO PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. NO DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. THE EVENT OCCURRED INTRA-OPERATIVE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779113 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 0000346686 00389701011820

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention 2.4FR COAXIAL PROGREAT| 4FR MICROPUNCTURE SYSTEM| 5FR GUIDE CATH| 6FR BRITE-TIP CORDIS SHEATH| BENTSON WIRE & GLIDE WIRE| CONTRAST(ISOVUE 300)| Y90 -SIRSPHERE