BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8FR ANGIO-SEAL STS PLUS OUS

    MDR report key: 6642954 · Received June 15, 2017

    Report

    Report Number
    3013394970-2017-00093
    Event Type
    Malfunction
    Date Received
    June 15, 2017
    Date of Event
    May 17, 2017
    Report Date
    June 15, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    05414734005012
    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 MANUFACTURER 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 WAS CONDUCTED WITH NO RELEVANT FINDINGS. A SEARCH OF THE COMPLAINT FILE FOUND ONE SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. 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

    THE REPORT IS BEING SUBMITTED AS FOLLOW-UP NO. 1 TO PROVIDE THE EVALUATION RESULTS. ONE 8F ANGIOSEAL STS PLUS WAS RETURNED TO TERUMO MEDICAL CORPORATION IN (B)(4) FOR EVALUATION. THE FOLLOWING COMPONENTS WERE RETURNED: CARRIER TUBE ASSEMBLY, ARTERIOTOMY LOCATOR, HEMOSTASIS SHEATH, ALUMINUM POUCH AND THE TYVEK POUCH. THE BYPASS TUBE WAS RETURNED SEPARATE FROM THE CARRIER TUBE ASSEMBLY. SOME COLLAGEN EXPANSION WITHIN THE CARRIER TUBE COULD BE MADE OUT. FOR FUNCTIONAL TESTING THE BYPASS TUBE WAS ADVANCED TO THE TIP OF THE CARRIER TUBE AND THE ANCHOR WAS ENSCONCED INSIDE THE BYPASS TUBE. THE CARRIER TUBE ASSEMBLY WAS MATED WITH AN AVAILABLE HEMOSTASIS SHEATH BY INSERTING THE BYPASS TUBE IN THE VALUE OF THE SHEATH HUB. THE CARRIER TUBE ADVANCED AS INTENDED AND UPON REACHED FORWARD LOCK POSITION THE ANCHOR POSTED AGAINST THE SHEATH TIP. THE DEPLOYMENT SLEEVE WAS EXTENDED TO REAR LOCK POSITION AND THE ANCHOR WAS PULLED OUT TO REVEAL COLLAGEN AND INTACT SUTURE KNOT. THE COLLAGEN WAS SOAKED IN WATER AND THE TAMPING TUBE WAS ADVANCED OVER IT (UNTIL BLACK MARKER WAS VISIBLE) TO FORM A SUCCESSFUL KNOT. THE DEVICE FUNCTIONED AS INTENDED. THE CARRIER TUBE OUTER DIAMETER WAS MEASURED TO BE 0.1018" AND INNER DIAMETER OF THE BYPASS TUBE WAS FOUND TO BE 0.110" AT THE DISTAL END AND .099" AT THE PROXIMAL END. THESE DIMENSIONS WERE CONFORMING TO THE SPECIFICATIONS ACTIVE AT THE TIME OF MANUFACTURING AS MENTIONED IN THE DHR. THE EXACT ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED BUT IT IS LIKELY THAT THE BYPASS TUBE SHIFTED FROM IT MANUFACTURING POSITION EITHER DUE TO IMPROPER OPENING OF THE ALUMINUM POUCH OR MISHANDLING AFTER OPENING. THE COMPLAINT CANNOT BE CONFIRMED. HE ANCHOR WAS DEPLOYED UPON RECEIPT BUT IT IS LIKELY THAT THE DEPLOYMENT OCCURRED AFTER IMPROPERLY OPENING THE PACKAGE OR MISHANDLING THEREAFTER. THE RETURNED DEVICE WAS FUNCTIONALLY AND DIMENSIONALLY TESTED WITH NO ANOMALIES FOUND. NO RELATED ISSUES WERE NOTED DURING DHR REVIEW FOR THIS PRODUCT/LOT. THERE HAVE BEEN NO PREVIOUS REPORTS WITH THIS PART/LOT NUMBER COMBINATION. 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. 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 THAT THE ANGIO SEAL DEVICE WAS DETACHED WHEN UNPACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: WHEN THE FOIL POUCH WAS OPENED, THE BYPASS TUBE WAS DETACHED ON THE ANGIO SEAL DEVICE; THE DETACHED ANGIO SEAL DEVICE WAS NOT USED; A NEW ANGIO SEAL DEVICE WAS USED TO CONTINUE THE PROCEDURE; THERE WERE NO REPORTED OBSTACLES THAT WOULD HAMPER THE USER TO UNPACK THE ANGIO SEAL DEVICE; THERE WAS NO HEALTH DAMAGE TO THE PATIENT; AND THERE WAS NO REPORTED BLOOD LOSS. PUNCTURE VESSEL: FEMORAL ARTERY - RIGHT - PUNCTURE SITE: DISTAL OF INGUINAL LIGAMENT. VESSEL DIAMETER: 5 MM SIZE OF THE SHEATH ANCILLARY USED: 8 FR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425722 8FR ANGIO-SEAL STS PLUS OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION NA 5758885 05414734005012

    Patients

    Seq Age Sex Outcome Treatment
    1