BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 8416006 · Received March 13, 2019

    Report

    Report Number
    9612164-2019-00860
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    March 7, 2019
    Report Date
    April 1, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS SINCE RETURNED FOR A FOLLOW-UP APPOINTMENT 4 DAYS LATER AND IT WAS DETERMINED THAT THE VEIN WAS CLOSED UP TO THE SFJ AND THE PATIENT IS DOING WELL. PATIENT WILL CONTINUE TO BE MONITORED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PHYSICIAN USED VENASEAL TO TREAT A PATIENT¿S GREAT SAPHANEOUS VEIN (GSV). THE IFU WAS FOLLOWED AND A GUIDEWIRE WAS USED FOR THE PROCEDURE. IT WAS REPORTED THAT THE SFJ FAILED TO CLOSE AT THE JUNCTION AFTER THE INITIAL TWO ALIQUOTS WERE ADMINISTERED AND THREE MINUTE HOLD WAS PERFORMED. THE VEIN MEASURED 1.6CM AND APPEARED TO BE PATENT AT THE JUNCTION. THE PHYSICIAN BELIEVED THAT THE ADHESIVE USED IN THE INITIAL TREATMENT BECAME BALLED UP AND STUCK TO THE CATHETER TIP CONTRIBUTING TO THE INCOMPLETE CLOSURE OF THE VEIN. A PIECE OF ADHESIVE APPEARED TO BE ATTACHED TO THE WALL OF THE VEIN DISTAL TO THE JUNCTION ALTHOUGH IT WAS NOT MOVING THERE IS SOME CONCERN THAT IT MAY DISLODGE. SUBSEQUENT TREATMENTS IN EIGHT SEGMENTS CLOSED THE REMAINDER OF THE VEIN. THE PROCEDURE WAS COMPLETED AND NO ADDITIONAL TREATMENT WAS REQUIRED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210827 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1