BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US

    MDR report key: 19834355 · Received July 25, 2024

    Report

    Report Number
    3013394970-2024-00339
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    June 25, 2024
    Report Date
    July 25, 2024
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011813
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE OR DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3A: SEX: REQUESTED, NOT PROVIDED. A3B: GENDER: N/A. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: LEAD TECH. 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. 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 SENT AS FOLLOW-UP NO. 1 TO PROVIDE ADDITIONAL INFORMATION TO SECTION A, B5, H11 AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ONE (1) 8FR ANGIO-SEAL DEVICE WAS RETURNED FOR PRODUCT EVALUATION. THE RETURNED DEVICE INCLUDED THE HEMOSTASIS SHEATH AND PACKAGING. THE DEVICE WAS VISUALLY INSPECTED AND FOUND TO HAVE BEEN IN USED CONDITION WITH VISIBLE SIGNS OF BLOOD. THE HEMOSTASIS SHEATH WAS FOUND TO HAVE BEEN FRACTURED INTO MULTIPLE PIECES. THE COMPONENT WAS ALSO ABLE TO BE BROKEN IN A MANNER WHICH IS CONSISTENT WITH EMBRITTLEMENT DUE TO LIGHT EXPOSURE. THE COMPLAINT WAS CONFIRMED FOR A SHEATH BREAKAGE DUE TO LIGHT EXPOSURE. THE LIKELY CAUSE WAS DETERMINED TO HAVE BEEN IMPROPER STORAGE AS THE DEVICE WAS STORED IN A PYXIS SYSTEM AND WAS BROKEN IN A MANNER WHICH IS CONSISTENT WITH EMBRITTLEMENT DUE TO LIGHT EXPOSURE. 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 FOOT PLATE BROKE OFF DURING DEPLOYMENT. THE ANCHOR WAS SURGICALLY REMOVED BY A VASCULAR SURGEON. NO BLOOD LOSS WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 26 JUN 2024: IT WAS CONFIRMED THAT THE SHEATH BROKE INTO PIECES IN THE PATIENT AND HAD TO BE SURGICALLY REMOVED. ADDITIONAL INFORMATION WAS RECEIVED ON 27 JUN 2024: THE PATIENT'S CONDITION WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 01 JUL 2024: THE PRODUCT WAS DISCOVERED TO BE PLACED UNBOXED IN THE PYXES SYSTEM, AND WARNINGS WERE ONLY VISIBLE ON THE BOX. AS OF 12 JUL 2024, ALL ITEMS WERE REMOVED FROM THE RADIOLOGY LAB'S LIGHT. ADDITIONAL INFORMATION WAS RECEIVED ON 17 JUL 2024: THE DEVICE DID NOT DEPLOY PROPERLY WITH THE HEMOSTATIC SHEATH DEMONSTRATING A FAILURE INTO MULTIPLE PIECES. COMPLICATIONS OF SURGERY PROCEDURE IN PATIENT. TEMPORARY INTERVENTION NEEDED. ON (B)(6) 2024, FOLLOWING A MECHANICAL THROMBECTOMY, AN ATTEMPTED CLOSURE WAS INITIATED WITH AN 8FR ANGIO-SEAL DEVICE. THE DEVICE DID NOT DEPLOY PROPERLY; THE HEMOSTATIC SHEATH BROKE INTO MULTIPLE PIECES. AS MUCH EXTRAVASCULAR DEBRIS WAS REMOVED AS POSSIBLE. ON (B)(6) 2024, IT WAS DISCOVERED THAT THE LEFT LOWER EXTREMITY WAS PARTIALLY OBSTRUCTED BY A FOREIGN BODY, WHICH REQUIRED A THROMBECTOMY AND REMOVAL OF THE BROKEN ANGIO-SEAL CATHETER.

    Description of Event or Problem · 0

    MW 5157084 WAS RECEIVED ON 08/07/2024. ON (B)(6) 2024, A PATIENT UNDERWENT AN ARTERIOGRAM OF THE BRAIN AND LEFT MAIN CORONARY ARTERY THROMBECTOMY. THE CATHETERIZED VESSELS INCLUDED THE LEFT COMMON CAROTID ARTERY, LEFT MIDDLE CEREBRAL ARTERY, AND LEFT COMMON FEMORAL ARTERY. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. HOWEVER, WHEN CLOSING THE LEFT COMMON FEMORAL ARTERY PUNCTURE SITE WITH AN 8F ANGIO-SEAL DEVICE, THE DEVICE FAILED, NECESSITATING MANUAL PRESSURE TO ACHIEVE HEMOSTASIS. SUBSEQUENTLY, ON (B)(6) 2024, THE PATIENT REQUIRED VASCULAR SURGERY FOR A PARTIAL OCCLUSION CAUSED BY A FOREIGN BODY IN THE LEFT FEMORAL ARTERY, IDENTIFIED AS THE FRACTURED ANGIO-SEAL CATHETER SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1775727 8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION 610131 0000465914 00389701011813

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other| R