BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 7909237 · Received September 26, 2018

    Report

    Report Number
    9612164-2018-02533
    Event Type
    Injury
    Date Received
    September 26, 2018
    Date of Event
    August 29, 2018
    Report Date
    September 26, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE EVALUATION: THE VENASEAL KIT WAS RETURNED FOR EVALUATION. THE FOLLOWING ITEMS WERE RETURNED: THE OPENED LABELLED SHELF CARTON, LABELLED TYVEK LID COVER, KIT TRAY WITH LID, 3CC SYRINGE, 5CC VIAL OF ADHESIVE, PROTECTIVE TRANSPORTATION SHEATH TUBING, ADHESIVE GUN, 3CC SYRINGE FILLED WITH ADHESIVE, CATHETER, DILATOR WITH 0.035¿ GUIDEWIRE AND THE BLUE 7FR INTRODUCER IN TWO PIECES. TENSILE STRETCHING COULD BE SEEN ON THE MOST DISTAL SEGMENT OF THE BLUE 7FR INTRODUCER. A KINK IN THE BLUE 7FR INTRODUCER WAS NOTED APPROXIMATELY 2.5CM DISTAL OF THE BLUE 7FR HUB¿S DISTAL TIP. THE BLUE INTRODUCER EXHIBITED A TENSILE SEPARATION AT APPROXIMATELY 53.7CM DISTAL OF THE BLUE 7FR INTRODUCER HUB¿S DISTAL TIP. THE DISTAL SEGMENT OF THE BLUE 7FR INTRODUCER EXHIBITED APPROXIMATELY 15.8CM OF TENSILE STRETCHING BETWEEN 53.7CM AND 69.5CM. THE OVERALL LENGTH OF THE RETURNED BLUE 7FR INTRODUCER WAS APPROXIMATELY 89CM. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A VENASEAL TO TREAT THE GREAT SAPHENOUS VEIN (GSV) AS PER THE IFU. THE LUMEN WAS FLUSHED PRIOR TO USE. LOCAL ANESTHESIA AND HAND COMPRESSION WERE USED. IT WAS REPORTED THE PHYSICIAN ADVANCED THE BLUE INTRODUCER INTO THE PATIENT BUT HE MET WITH EXTREME RESISTANCE INSIDE THE VEIN. HE THEN ATTEMPTED TO WITHDRAW THE INTRODUCER BUT IT BECAME STUCK INSIDE THE PATIENT. THE PHYSICIAN BEGAN TO WITHDRAW THE INTRODUCER WITH FORCE BUT THE INTRODUCER SNAPPED AND BROKE APART. THE PHYSICIAN USED THE BLUE HEMOSTAT TO GRAB HOLD OF A PIECE OF THE BLUE INTRODUCER STILL INSIDE THE PATIENT AND SLOWLY WITHDREW 1/2 CM AT A TIME UNTIL FULLY OUT OF THE BODY. THE PATIENT EXPERIENCED EXTREME PAIN THROUGHOUT THE PROCEDURE. AFTER REMOVING THE LAST PIECE OF THE BLUE INTRODUCER FROM THE PATIENT, THE PHYSICIAN MADE THE DECISION TO END THE PROCEDURE. THE PATIENT WAS NOT TREATED WITH VENASEAL AND NO GLUE WAS IMPLANTED. THE PROCEDURE WAS NOT COMPLETED AND NO VEIN WAS TREATED. PATIENT WILL RETURN AT A LATER DATE FOR FURTHER CONSULTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750946 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND 51794

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Required Intervention