BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US

    MDR report key: 15031604 · Received July 15, 2022

    Report

    Report Number
    3013394970-2022-00212
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011820
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PHONE NUMBER: UNKNOWN. ESTABLISHMENT ADDRESS: UNKNOWN. OCCUPATION: RISK MANAGER. TERUMO TMC PERFORMED A MAUDE SEARCH ON 30 JUN 2022. REPORT NUMBER MW5109955 WAS FOUND AND WAS CONFIRMED TO BE OF THE SAME REPORTED EVENT; THEREFORE, THE MAUDE REPORT HAS BEEN PROVIDED. THE ACTUAL DEVICE WAS NOT AVAILABLE; THEREFORE, THE ACTUAL DEVICE WILL NOT BE 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 SUBMITTED AS FOLLOW UP NO. 1 TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. AN EXACT ROOT CAUSE FOR THE ISSUE WAS UNABLE TO BE DETERMINED. THE LIKELY CAUSE WAS DETERMINED TO HAVE BEEN AN OBSTRUCTION TO THE ANCHOR POSTING TO THE TIP OF THE HEMOSTASIS SHEATH. 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. THE RISK LEVEL IS WITHIN LIMITS; HOWEVER, THERE IS AN INCREASE IN OCCURRENCE LEVEL. AN ACTION ITEM WAS OPENED TO ADDRESS THE ISSUE AND HAS BEEN SENT TO THE NEW PRODUCT DEVELOPMENT (NPD) QUALITY TEAM.

    Description of Event or Problem · 0

    TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5109955. THE EVENT DESCRIPTION STATES: A 6FR ANGIO-SEAL MALFUNCTION. THE FOOT PLATE OF THE DEVICE WAS NOT RELEASED OUT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2723281 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 0000151758 00389701011820

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown