BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 10935019 · Received December 2, 2020

    Report

    Report Number
    3013394970-2020-00780
    Event Type
    Injury
    Date Received
    December 2, 2020
    Date of Event
    November 5, 2020
    Report Date
    December 2, 2020
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED 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. THE COMPLAINT CAN BE CONFIRMED FOR ALLEGED FAILURE THAT THE USER EXPERIENCED. THE CAUSE OF THE ISSUE CANNOT BE CONCLUSIVELY DETERMINED IN THE ABSENCE OF THE DEVICE AND WITH THE AVAILABLE INFORMATION. THE INSTRUCTIONS FOR USE SPEAK TO THE NEED TO "MONITOR THE PATIENT (FOR AT LEAST 24 HOURS) FOR SIGNS OF VASCULAR OCCLUSION AND THE RISK OF COLLAGEN DEPOSITION INTO THE ARTERY. 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 FMEA.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT 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.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE ANGIO-SEAL DEVICE WAS USED FOR ELECTIVE ENDOVASCULAR THERAPY (EVT), WHICH WAS PERFORMED FOR CHRONIC TOTAL OCCLUSION (CTO) OF THE RIGHT COMMON ILIAC ARTERY (CIA). A SMART STENT (CORDIS) WAS IMPLANTED IN THE RIGHT CIA AND THE DEVICE WAS USED FOR HEMOSTASIS IN THE PROCEDURE. ON THE NEXT DAY OF THE PROCEDURE, AS THE PATIENT HAD LAMENESS, AN ECHOGRAPHY WAS PERFORMED. BASED ON THE FINDINGS, THROMBUS OCCLUSION WAS SUSPECTED AND EMERGENCY EVT WAS PERFORMED. A GLIDE SHEATH SLENDER AND A SLENGUIDE GUIDING CATHETER WERE USED FOR APPROACHING FROM THE LEFT RADIAL ARTERY. VESSEL OCCLUSION IN THE DISTAL PART TO THE STENT WAS CONFIRMED WITH THE ANGIOGRAPHY. THEN A RADIFOCUS GUIDEWIRE (RF-(B)(4)) WAS CHANGED TO A JUPITER FC 300CM (BOSTON SCIENTIFIC) AND OBSERVED LESION WITH A NAVIFOCUS WR. USING INTRAVASCULAR ULTRASOUND (IVUS), THE DEVICE SITE WAS CHECKED, AND THROMBUS WAS OBSERVED. AFTER IVUS, THROMBUS WAS ASPIRATED WITH A THROMBUSTER 7FR GL (KANEKA) AND COLLAGEN SPONGE LIKE SUBSTANCE WAS REMOVED FROM THE PATIENT. AS THERE WAS A POSSIBILITY THAT THE ANCHOR WAS LEFT IN THE PATIENT, THE PATIENT WAS SENT TO SURGICAL PROCEDURE. THE DEVICE RELATED SUBSTANCES INCLUDING THE ANCHOR WAS ABLE TO BE COLLECTED NEAR THE PUNCTURE SITE AND REMOVED FROM THE PATIENT. POSSIBLE CAUSES OF INVASION OF THE COLLAGEN INTO VESSEL ARE THE GUIDING SHEATH USED WAS A PARENT PLUS 6FR (MEDIKIT), THE ANGIO-SEAL DEVICE SIZE WAS ALSO 6FR, AND MANUAL COMPRESSION WAS APPLIED ON THE PUNCTURE SITE AFTER THE DEVICE WAS USED. THE PROCEDURE BEFORE DEPLOYING THE DEVICE WAS A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI). A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THE SIZE OF THE SHEATH ANCILLARY USED WAS 6 FR. THE PUNCTURE SITE WAS DISTAL TO THE INGUINAL LIGAMENT OF THE RIGHT COMMON FEMORAL ARTERY. THE VESSEL DIAMETER WAS 6 MM. THE ESTIMATED BLOOD LOSS WAS LESS 250CC. THE PATIENT WAS RECOVERING. PPI WAS APPLIED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS HOSPITALIZED EXTENDED DUE TO THE EVENT. THE PATIENT REQUIRED SURGICAL INTERVENTION DUE TO THE EVENT, PPI. AN ULTRASOUND WAS PERFORMED TO DIAGNOSE THE VASCULAR INSUFFICIENCY. AN ANGIOGRAM WAS PERFORMED TO DIAGNOSE THE VASCULAR INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398423 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 06102602

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R PARENT PLUS 6FR (MEDIKIT).| SLENGUIDE GUIDING CATHETER 120CM.| SMART STENT (CORDIS).| THROMBUSTER 7FR GL (KANEKA).