BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US

    MDR report key: 19272893 · Received May 8, 2024

    Report

    Report Number
    3013394970-2024-00187
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 5, 2024
    Report Date
    May 8, 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
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E3: OCCUPATION: REGISTERED TECH (RT). THE ACTUAL DEVICE HAS NOT 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 PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. SINCE THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION, THE COMPLAINT COULD NOT BE CONFIRMED. THE EXACT ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE LIKELY CAUSE WAS DETERMINED TO HAVE BEEN AN OBSTRUCTION TO THE DISTAL TIP PREVENTING PROPER DEPLOYMENT OF THE COMPONENTS. 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)/HAZARD BASED RISK TABLE (HBRT).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE INVOLVED ACCORDING TO THE CUSTOMER THE ANGIO-SEAL FAILED DUE TO NOTHING COMING OUT OF THE ANGIO-SEAL SHEATH. WHEN THEY PULLED THE SYSTEM BACK TO DEPLOY THE VCD EVERYTHING CAME OUT AND LEFT NOTHING IN THE PATIENT. MANUAL PRESSURE WAS HELD. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 09 APR 2024: THE PROCEDURE PERFORMED WAS A GAE (GENICULAR ARTERY EMBOLIZATION). THE SHEATH SIZE USED WAS A 5FR. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. THERE WERE ISSUES WITH DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140610 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 0000463282 00389701011820

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| C