BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 6636879 · Received June 13, 2017

    Report

    Report Number
    3013394970-2017-00088
    Event Type
    Malfunction
    Date Received
    June 13, 2017
    Date of Event
    May 12, 2017
    Report Date
    June 13, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED TO THE MANUFACTURING FACILITY 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 COULD NOT BE CONDUCTED DUE TO THE UNKNOWN LOT NUMBER. A SEARCH OF THE COMPLAINT FILE COULD NOT BE CONDUCTED DUE TO THE UNKNOWN LOT NUMBER. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. DEVICE IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. TO PROVIDE THE EVALUATION RESULTS. ONE 8F ANGIOSEAL STS PLUS WAS RETURNED TO TERUMO MEDICAL CORPORATION AT (B)(4) FOR EVALUATION. ONE CARRIER TUBE ASSEMBLY WAS RETURNED MATED WITH A HEMOSTASIS SHEATH. THE DEPLOYMENT SLEEVE WAS IN THE REAR LOCK POSITION. THE LEADING LEG OF THE UNDEPLOYED ANCHOR WAS VISIBLE THROUGH THE HEMOSTASIS SHEATH. THERE WAS BLOOD LIKE SUBSTANCE OBSERVED ON ALL RETURNED COMPONENTS. NO ANOMALIES WERE NOTED ON THE MONOFOLD AT THE HEMOSTASIS SHEATH TIP. FOR FUNCTIONAL TESTING, THE DEVICE WAS PUSHED TO THE FULL FORWARD LOCK POSITION AND THE ANCHOR POSTED ON THE DEVICE AS INTENDED. THE TIP OF THE DEVICE WAS SOAKED IN WATER AND THE ANCHOR WAS PULLED TO REVEAL BLUE TAMPER TUBE AND COLLAGEN. THE TAMPER TUBE WAS MANUALLY ADVANCED OVER THE COLLAGEN AND THE KNOT WAS SUCCESSFULLY FORMED. THE BYPASS TUBE DISTAL END INNER DIAMETER WAS MEASURED TO BE 0.110" AND THE OUTER DIAMETER OF THE PROXIMAL TIP OF THE BYPASS TUBE WAS FOUND TO BE 0.314".THE LENGTH OF EXTRUDED PORTION OF BYPASS TUBE THAT PRESSES FLUSH AGAINST THE HEMOSTASIS SHEATH HUB WAS 0.189" .THE CIRCULAR HOLE IN DEPLOYMENT SLEEVE WHICH GOES AROUND AND OVER THE BYPASS TUBE WAS FOUND TO BE 0.338".THESE MEASUREMENTS WERE CONFIRMED TO MEET MANUFACTURER SPECIFICATION. THE EXACT ROOT CAUSE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION BUT THE OVERALL DEVICE CONDITION IS CONSISTENT WITH FULL OR PARTIAL EXTENSION OF THE DEPLOYMENT SLEEVE PRIOR TO INSERTION INTO THE HEMOSTASIS SHEATH LEADING TO NON DEPLOYMENT OR RESISTANCE ENCOUNTERED DURING CARRIER TUBE ADVANCEMENT THROUGH THE HEMOSTASIS SHEATH RESULTING IN THE ANCHOR NOT EXITING THE SHEATH DISTAL TIP. UPON FUNCTIONAL AND DIMENSIONAL TESTING NO ANOMALIES WERE FOUND AND THE DEVICE WORKED AS INTENDED. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED DIFFICULTY WITH THE INVOLVED ANGIO-SEAL DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: UNABLE TO INSERT INTO THE INSERTION SHEATH; THE TIP OF THE COMPONENT WAS DEFORMED AND THE COMPONENT WAS NOT INSERTED INTO THE INSERTION SHEATH; A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE; HEMOSTASIS WAS ACHIEVED SUCCESSFULLY WITH THE NEW ANGIO-SEAL DEVICE; AND THERE WAS NO REPORTED HEALTH DAMAGE TO THE PATIENT. ADDITIONAL INFORMATION ON MAY 21, 2017. THE DAMAGE WAS A RESULT OF ATTEMPTED INSERTION. THE COMPONENT WAS BEING INSERTED INTO THE CARRIER TUBE ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418328 8F ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1