BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 7977949 · Received October 18, 2018

    Report

    Report Number
    9612164-2018-02814
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    September 21, 2018
    Report Date
    December 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

    THE PROCEDURE WAS CARRIED OUT AS PER IFU WITHOUT ANY DEVIATION. THE CATHETER TIP WAS POSITIONED 5 CM AWAY FROM THE SAPHENO-FEMORAL JUNCTION (SFJ) AND WAS VISUALIZED UNDER ULTRASOUND GUIDANCE. THE FOLLOW UP VISIT WAS TWO WEEKS POST PROCEDURE WHEN THE PATIENT WAS EVALUATED AND TREATMENT PRESCRIBED. THE PHYSICIAN REPORTED THAT THE PATIENT¿S SYMPTOMS HAVE RESOLVED. 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

    IT WAS REPORTED THAT THE PATIENT HAD TREATMENT OF GREAT SAPHENOUS VEIN (GSV) USING VENASEAL. POST PROCEDURE THE PATIENT EXPERIENCED SWELLING OF THE HANDS, ITCHING AND REDNESS IN THE LEGS (AROUND TREATED AREA) AND RED PATCHES ON THE SIDE OF THE BODY. ULTRASOUND IDENTIFIED A THROMBUS ADHERENT TO THE SFJ WHICH WAS TREATED WITH ANTICOAGULANTS. THE PHYSICIAN PRESCRIBED NSAIDS AND PATIENT HAD IV FOR THE IRRITATION. THE PATIENT HAS SINCE BEEN DISCHARGED AND IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821507 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention