BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 8965713 · Received September 5, 2019

    Report

    Report Number
    2243441-2019-00079
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Date of Event
    August 15, 2019
    Report Date
    September 5, 2019
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE DEVICE RETURN DATE IN SECTION D10: CONCOMITANT MEDICAL PRODUCTS, UPDATE SECTION H3: DEVICE EVALUATED BY MFR, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ONE USED 8F ANGIO-SEAL EVOLUTION DEVICE WAS RECEIVED FOR PRODUCT EVALUATION. THE HEMOSTASIS SHEATH WAS RETURNED MATED WITH THE CARRIER TUBE ASSEMBLY. NO OTHER ACCESSORY COMPONENTS WERE RECEIVED. VISUAL INSPECTION REVEALED THAT THE SUTURE WAS RELEASED AT THE DISTAL TIP OF THE SHEATH. THERE WAS NO KINK OR DEFORMATION NOTICED ON THE DEVICE. THE CARRIER TUBE ASSEMBLY WAS APPROPRIATELY MATED WITH THE HEMOSTASIS SHEATH AND THE DEPLOYMENT SLEEVE WAS IN THE FULL REAR LOCK POSITION WITH THE COLOR BANDS FULLY EXPOSED. THE BUTTON WAS STIFF UPON RECEIPT. NO COMPACTION TUBE, ANCHOR AND COLLAGEN WERE RETURNED. NO OTHER VISUAL ANOMALIES WERE NOTED. THE DEVICE WAS DIS-ASSEMBLED, AND THE GEARBOX ASSEMBLY WAS VISUALLY INSPECTED. THE GEARBOX ASSEMBLY WAS IN A COMPLETELY DISTAL POSITION ALONG WITH THE RACK. THE SUTURE COULD BE SEEN TETHERED TO THE SUTURE STAKE. THERE WERE NO TURNS OF THE SUTURE COULD BE SEEN WITHIN GROOVES OF THE SPOOL. FUNCTIONAL TESTING WAS PERFORMED BY TURNING THE DRIVE GEAR CLOCKWISE RETRACTING THE RACK. NO ANOMALIES WERE NOTED. THE GEAR WAS THEN TURNED COUNTERCLOCKWISE AND AGAIN NO ANOMALIES WERE NOTED WITH THE MOVEMENT OF THE RACK. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE INVESTIGATION RESULTS VERIFIED THE RETURNED SAMPLE WAS OF THE NORMAL PRODUCT. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    EXPLANTED DATE: DEVICE WAS NOT EXPLANTED TITLE- PROF. AND DOCTOR. 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 INVOLVED ANGIO-SEAL DEVICE WAS USED FOR CLOSURE AFTER THE DOCTOR HAD PREPARED THE PATIENT, WITH INTENTION TO DO CTO RECANALIZATION. USING BIFEMORAL APPROACH; BOTH FEMORAL ARTERIES WERE PUNCTURED WITH 7F SHEATHS, HE DID THE PROCEDURE AND PERFORMED AN ANGIOGRAM OF BOTH FEMORAL ARTERIES WHICH SHOWED PROPER PUNCTURE SITE AND VESSEL CHARACTERISTICS. WITH THE FIRST DEVICE; WHEN THE DOCTOR WAS PULLING BACK THE ANGIO-SEAL DEVICE TO SEAL THE PUNCTURE, THE MECHANISM DID NOT PUSH TAMPING TUBE AS EXPECTED. THE SUTURE BECAME VISIBLE BETWEEN THE SKIN AND REMAINING PART OF THE DEVICE. HE TOOK THE SMALL PART OF TAMPING TUBE WHICH WAS VISIBLE; PULLED IT OUT OF THE SHEATH AND TAMPED THE COLLAGEN MANUALLY, THE BUTTON WAS PRESSED, AND THE SUTURE WAS RELEASED AND CUT. WITH SECOND PUNCTURE, HE HAD TO PULL BIT HARDER THAN USUAL; HOWEVER, THAT TAMPING TUBE DID DEPLOY AND THE COLLAGEN WAS COMPACTED. HEMOSTASIS WAS INSTANT ON BOTH PUNCTURE SIGHTS. THERE WAS NO HARM TO THE PATIENT AND THERE WAS NO BLOOD LOSS. A 7FR SHEATH WAS USED. THE PROCEDURE WAS CHRONIC TOTAL OCCLUSION. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757898 8F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION NA 6889308

    Patients

    Seq Age Sex Outcome Treatment
    1