BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 7706113 · Received July 20, 2018

    Report

    Report Number
    9612164-2018-01810
    Event Type
    Injury
    Date Received
    July 20, 2018
    Date of Event
    June 20, 2018
    Report Date
    October 5, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPONENTS FROM THE VENASEAL CLOSURE SYSTEM KIT WAS RECEIVED FOR EVALUATION. NO PHOTOGRAPHIC IMAGES OF THE PATIENT¿S SYMPTOMS WERE RECEIVED FOR EVALUATION. THREE SONOGRAPHIC VIDEOS WERE PROVIDED FOR REVIEW. THE SONOGRAPHIC VIDEOS SHOW A PROTRUSION OF MATERIAL INTO THE SAPHENOUS FEMORAL JUNCTION FROM THE GREAT SAPHENOUS VEIN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED VENA SEAL TREATMENT OF THEIR GREAT SAPHENOUS VEIN (GSV). THE PATIENT WAS PREPPED AND DRAPED IN NORMAL STERILE FASHION AND THE VENASEAL DEVICE WAS PREPPED AND PRIMED ACCORDING TO THE IFU. ACCESS TO THE VEIN WAS ACHIEVED AND THE .035 WIRE WAS PLACED AT THE SFJ. THE BLUE GUIDECATH WAS PLACED AT THE JUNCTION. THE WIRE AND GREY INNER DILATOR WERE REMOVED AND A SALINE FLUSH SYRINGE WAS PLACED ON THE BACK OF THE GLUE CATH. UNDER ULTRASOUND GUIDANCE, THE TIP OF THE BLUE GUIDECATH WAS OBSERVED AT THE SFJ AND THEN PULLED BACK 5CM. THE PRIMED GLUE CATHETER WAS INSERTED INTO THE GUIDECATH AND UP TO THE LASER MARK. AT THAT POINT, THE ENTIRE UNIT WAS PULLED BACK ANOTHER 5CM AND THEN THE GLUE CATHETER WAS CONNECTED TO THE BLUE GUIDECATH. UNDER ULTRASOUND GUIDANCE THE TIP OF THE GLUE CATHETER WAS CONFIRMED TO BE 5CM AWAY FROM THE SFJ. THE SONOGRAPHER HELD COMPRESSION 2CM FROM THE TIP OF THE GLUE CATHETER AND COMPRESSED THE GSV TO BLOCK FORWARD MOVEMENT OF THE ADHESIVE. ADHESIVE WAS ADMINISTERED ACCORDING TO THE IFU AND COMPRESSION WAS HELD FOR 3 MINUTES WITH THE TRANSDUCER AND THE SONOGRAPHER'S HAND. THE REST OF THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION AND THE PATIENT WENT HOME WITH DISCHARGE INSTRUCTIONS. AT A FOLLOW UP ULTRASOUND, 72 HOURS POST OP, IT WAS NOTED THAT THERE MAY BE A THROMBUS / GLUE EXTENSION INTO OR UP TO THE SFJ. PATIENT WAS PLACED ON ELIQUIS AND WILL RETURN FOR FOLLOW UP SCANS. OPINION THROMBUS WAS CAUSED BY INCOMPLETE COMPRESSION OF THE VEIN DUE TO AWKWARD POSITIONING OF PERSONNEL DURING THE PROCEDURE. THE PATIENT FEELS FINE. HAS NO SYMPTOMS AND HIS LEG HAS NEVER FELT BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548215 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND 50826

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention