BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 7762187 · Received August 8, 2018

    Report

    Report Number
    9612164-2018-01983
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    July 9, 2018
    Report Date
    October 3, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    IMAGE REVIEW: THREE SONOGRAPHIC IMAGES WERE RECEIVED FOR EVALUATION. THE THREE IMAGES INCLUDE THE SFJ, COMMON FEMORAL VEIN, AND FEMORAL ARTERY. IMAGE 1 IS OF THE LEFT COMMON FEMORAL VEIN AND THE SFJ IN A LONGITUDINAL PLANE. IMAGE 2 IS OF THE LEFT COMMON FEMORAL VEIN AND THE SFJ IN A TRANSVERSE PLANE. IMAGE 3 IS OF THE LEFT COMMON FEMORAL VEIN AND THE SFJ IN A LONGITUDINAL PLANE. A MASS OF THROMBOSIS CAN BE SEEN IN ALL THREE IMAGES. BASED ON THE QUALITY AND CLARITY OF THE IMAGES IT IS NOT POSSIBLE TO POSITIVELY DETERMINE IF THE THROMBOSIS MASS INCLUDES ADHESIVE. NO COMPONENTS FROM THE VENASEAL CLOSURE SYSTEM KIT WERE RECEIVED FOR EVALUATION. NO PHOTOGRAPHIC IMAGES OF THE PATIENT¿S SYMPTOMS WERE RECEIVED FOR EVALUATION. 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 A PATIENT WAS TREATED WITH VENA SEAL AS PER THE IFU IN THE GREAT SAPHENOUS VEIN(GSV). APPROXIMATELY A 30CM LENGTH WAS TREATED WITH 1 CM OF CYANOACRYLATE. THE CATHETER TIP LOCATION WAS 5CM CAUDAL TO THE SAPHENOFEMORAL JUNCTION (SFJ) PRIOR TO INITIAL DELIVERY OF THE ADHESIVE AS PER THE IFU. THE PATIENT RETURNED FOR A FOLLOW UP STUDY AND IT WAS FOUND THAT GLUE HAD EXTENDED CLOSE TO THE COMMON FEMORAL VEIN. THE PATIENT WAS PRESCRIBED BLOOD THINNERS AS A RESULT OF THE GLUE EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602047 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention