BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 6833531 · Received August 31, 2017

    Report

    Report Number
    2243441-2017-00107
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    July 24, 2017
    Report Date
    August 31, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1. ONE USED 6FR ANGIOSEAL EVOLUTION DEVICE WAS RECEIVED AT TERUMO MEDICAL CORPORATION FOR PRODUCT EVALUATION. NO ACCESSORY COMPONENTS WERE RETURNED WITH THE DEVICE. THE RETURNED DEVICE WAS SUBJECTED TO VISUAL ANALYSIS WHERE A BLOOD LIKE SUBSTANCE WAS FOUND ALONG THE DEVICE. THE BUTTON OF THE EVOLUTION WAS SOFT AND THE DEPLOYMENT SLEEVE WAS IN THE FORWARD POSITION WITH THE COLOR BANDS STILL CONCEALED IN THE BODY OF THE EVOLUTION DEVICE. THE COMPACTION MARKER ON THE COMPACTION TUBE COULD BE SEEN IN THE CARRIER TUBE ASSEMBLY THAT WAS EXPOSED. THE DEVICE WAS NOT MATED WITH A HEMOSTATIC SHEATH. THE ANCHOR WAS COMPLETELY EXPOSED AT THE DISTAL TIP OF THE CARRIER TUBE ASSEMBLY. THERE WAS NO MISSING MATERIAL OF THE BODY OF THE EVOLUTION. THE CARRIER TUBE ASSEMBLY APPEARED INTACT OTHER THAN THE MISSING BYPASS TUBE. THE PRONGS ON THE DEPLOYMENT SLEEVE WERE STILL INTACT. THERE WAS NO MISSING MATERIAL IN ANY OF THE COMPONENTS OBSERVED. ADDITIONALLY THE PIECE OF PLASTIC THAT REPORTEDLY BROKE OFF WAS NOT RETURNED. THE COMPLAINT COULD NOT BE CONFIRMED FOR DETACHED SEPARATED. IT IS POSSIBLE THAT THE PIECE OF PLASTIC THE PHYSICIAN WAS REFERRING TO WAS THE BYPASS TUBE, WHICH IS KNOWN TO BECOME DISLODGED FROM THE CARRIER TUBE ASSEMBLY IF THE POLYFOIL POUCH IS NOT COMPLETELY OPENED. THIS MAY EXPLAIN WHY THE ANCHOR AT THE DISTAL TIP OF THE CARRIER TUBE ASSEMBLY WAS NOT COVERED AND THE BYPASS TUBE WAS MISSING. HOWEVER, WITH THE INFORMATION PROVIDED AND THE RETURNED DEVICE THE COMPLAINT CANNOT BE CONFIRMED AND NO CONCLUSION CAN BE DRAWN. 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.

    Additional Manufacturer Narrative · 1

    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 RELEVANT FINDINGS. 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.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PIECE OF PLASTIC MATERIAL WAS DETACHED FROM THE DEVICE BEFORE USING IN THE PATIENT. THE DOCTOR THEN OPENED ANOTHER ONE AND FINISHED THE CASES WITHOUT FURTHER PROBLEM. IT WAS REPORTED THAT THE PATIENT WAS STABLE AND NO CONSEQUENCES OCCURRED. IT WAS A RIGHT FEMORAL ARTERY PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614629 6F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION NA 5789865

    Patients

    Seq Age Sex Outcome Treatment
    1