BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 7078445 · Received December 4, 2017

    Report

    Report Number
    9612164-2017-01708
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    June 3, 2017
    Report Date
    December 4, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. NO COMPONENT OF THE VENA SEAL CLOSURE SYSTEM WAS RETURNED FOR EVALUATION. FIVE PHOTOGRAPHS OF THE PATIENT¿S BOTH LEGS WERE PROVIDED FOR REVIEW. THE SWELLING AND RED SKIN COLOUR CHANGE COULD BE SEEN IN THE PHOTOGRAPHS OF BOTH OF THE PATIENT LEGS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PHYSICIAN USED THE VENASEAL SUCCESSFULLY TO TREAT THE GSV AND SSV AS PER IFU. THE PHYSICIAN TREATED BOTH LEGS, 4 SEGMENTS WERE TREATED AND CLOSED, TOTAL LENGTH APPROX. 90 CM WITH 3.2 CC OF CYANOACRYLATE USED. APPROX. 2 MONTHS¿ POST PROCEDURE THE PATIENT PRESENTED WITH ITCHING AND A RED SKIN COLOUR CHANGE, CHANGING TO A BLUE COLOUR IN BOTH LEGS AFTER STANDING FOR 1 HOUR. THIS SYMPTOM WAS CONSIDERED TO BE PHLEBITIS AND THE PATIENT WAS TREATED WITH NSAIDS AND ANTIBIOTICS. THE SYMPTOMS WERE RESOLVED AFTER A FEW DAYS. THE PATIENT HAS NO KNOWN ALLERGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860610 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention