BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 8821330 · Received July 24, 2019

    Report

    Report Number
    3013394970-2019-00583
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    July 15, 2019
    Report Date
    July 24, 2019
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE DEVICE RETURN DATE IN SECTION D10, AND TO UPDATE SECTION H3. 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 SUBMITTED AS FOLLOW UP NO. 2 TO UPDATE DEVICE INFORMATION, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ONE 6 FR ANGIO-SEAL VIP DEVICE WAS RECEIVED FOR PRODUCT EVALUATION. THE HEADER BAG WAS RETURNED ALONG WITH CARRIER TUBE ASSEMBLY MATED WITH THE HEMOSTASIS SHEATH. NO OTHER ACCESSORY COMPONENTS WERE RETURNED WITH THE DEVICE. VISUAL INSPECTION REVEALED THAT THE CARRIER TUBE ASSEMBLY WAS MATED WITH THE HEMOSTASIS SHEATH AND THE DEPLOYMENT SLEEVE WAS IN THE FULL REAR LOCK POSITION. THE ANCHOR HAD FULLY EXITED AT THE DISTAL TIP OF THE HEMOSTASIS SHEATH AS WOULD BE EXPECTED WHEN THE DEPLOYMENT SLEEVE WAS IN THE REAR LOCK POSITION. MICROSCOPIC ANALYSIS OF THE HUB OF THE CARRIER TUBE ASSEMBLY REVEALED THAT THE BYPASS TUBE WAS NOT PROPERLY MATED WITH THE SHEATH. NO OTHER VISUAL ANOMALIES WERE NOTED WITH THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED; THE DEVICE SLEEVE WAS SEPARATED FROM THE HEMOSTASIS SHEATH AND THE BYPASS TUBE WAS PROPERLY INSERTED INTO THE HEMOSTATIC VALVE. THEN, DEPLOYMENT SLEEVE WAS MANUALLY MOVED INTO THE FORWARD LOCK POSITION, WHICH CAUSED THE ANCHOR AND DISTAL TIP OF THE CARRIER TUBE TO BECOME EXPOSED. THE DEPLOYMENT SLEEVE WAS THEN MOVED INTO THE REAR LOCK POSITION AND THE ANCHOR POSTED TO THE SHEATH. THE DIGITAL FORCE WAS APPLIED TO THE ANCHOR AND THE SUTURE UNSPOOLED AS INTENDED WITH COLLAGEN; HOWEVER, THE TAMPER TUBE DID NOT EXIT FROM THE SHEATH. NO OTHER FUNCTIONAL ANOMALIES WERE NOTED WITH THE DEVICE. THE DEVICE WAS DISSECTED TO DISCOVER THE CAUSE OF OBSTRUCTION. THE CARRIER TUBE WAS CUT, AND THE PRESENCE OF THE TAMPER TUBE WAS CONFIRMED. DRIED BLOOD-LIKE SUBSTANCES WERE OBSERVED ON THE TAMPER TUBE. THERE WERE NO ANOMALIES WERE NOTED WITH THE TAMPER TUBE. THE TAMPER TUBE WAS DIMENSIONALLY MEASURED AND FOUND TO BE: THE OUTER DIAMETER OF THE TAMPER TUBE = 0.060''; THE INNER DIAMETER OF THE TAMPER TUBE =0.024''. ALL MEASUREMENTS WERE FOUND TO BE WITHIN MANUFACTURER SPECIFICATIONS. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT IS LIKELY THAT THE SHEATH WAS NOT PLACED INSIDE OF THE ARTERY OR SUBCUTANEOUS DEPLOYMENT. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 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. 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 ANCHOR DID NOT DEPLOY INTRA-ARTERIALLY; IT WAS NOT CUT OFF. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 18, 2019. A 6FR SHEATH WAS USED. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. HEMOSTASIS WAS ACHIEVED BY COMPRESSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614302 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 06091833

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention