BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6F ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 6537406 · Received May 2, 2017

    Report

    Report Number
    3013394970-2017-00038
    Event Type
    Malfunction
    Date Received
    May 2, 2017
    Date of Event
    April 4, 2017
    Report Date
    May 2, 2017
    Manufacturer
    TERUMO MEDICAL PRODUCTS
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE DEVICE RETURN DATE IN DEVICE AVAILABLE FOR EVALUATION?. 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.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS NOT 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 SEARCH OF THE COMPLAINT FILE DID NOT FIND ANY OTHER 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

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 3 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. 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 1) PROVIDE THE EVALUATION RESULTS 2) PROVIDE PATIENT INFORMATION. ONE 6F ANGIOSEAL STS PLUS WAS RETURNED FOR FUNCTIONAL EVALUATION AT TERUMO MEDICAL CORPORATION IN (B)(4). THE CARRIER TUBE ASSEMBLY WAS MATED WITH THE HEMOSTASIS SHEATH AND DEVICE WAS RETURNED WITH THE DEPLOYMENT SLEEVE IN REAR LOCK POSITION. THERE WAS BLOOD LIKE SUBSTANCE OBSERVED ON ALL RETURNED COMPONENTS. THE TAMPER TUBE WAS NOT RETURNED AND THE SUTURE APPEARED TORN AT THE TIP. 6.61" OF SUTURE WAS VISIBLE FROM THE TIP OF THE HEMOSTASIS SHEATH. BOTH BLACK AND CLEAR MARKERS WERE CLEARLY VISIBLE. THE CARRIER TUBE ASSEMBLY HUB CAP WAS REMOVED AND THE SUTURE WINDING MECHANISM WAS CHECKED; NO ANOMALIES WERE FOUND. BASED ON THE AVAILABLE INFORMATION IT IS LIKELY THAT OVERTIGHTENING LED TO SUTURE BREAK. SINCE THE TAMPER TUBE WAS NOT RETURNED THIS CANNOT BE CONFIRMED. ANGIOSEAL STS PLUS INSTRUCTIONS FOR USE (TIS-829-11232016) WERE REVIEWED AND PROVIDES ADEQUATE DETAIL AND ILLUSTRATION TO PREVENT OVERTIGHTENING. 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.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED BREAKAGE ON THE ANGIO-SEAL DEVICE DURING A CORONARY ANGIOGRAPHY PROCEDURE. THE FOLLOWING INFORMATION WAS REPORTED: THERE WAS BREAKAGE AT THE ORIGIN OF THE WIRE NEAR THE VALVE AT THE TIME OF WITHDRAWAL; IT WAS REPORTED THAT THERE WAS NO CERTAINTY ABOUT THE CORRECT IMPLANTATION; AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318982 6F ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, OUS HEMOSTASIS VASCULAR DEVICE MGB TERUMO MEDICAL PRODUCTS NA 5752391

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR