BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 11642222 · Received April 9, 2021

    Report

    Report Number
    9612164-2021-01404
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    September 2, 2020
    Report Date
    April 9, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL TITLE EXIT SITE COMPLICATIONS FOLLOWING CYANOACRYLATE GLUE ENDOVENOUS ABLATION OF INCOMPETENT TRUNCAL VEINS FOR CHRONIC VENOUS INSUFFICIENCY. HTTPS://DOI.ORG/10.1016/J.JVSCIT.2020.08.010. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS SUBMITTED DETAILING CASE REPORTS OF "EXIT SITE COMPLICATIONS FOLLOWING CYANOACRYLATE GLUE ENDOVENOUS ABLATION OF INCOMPETENT TRUNCAL VEINS FOR CHRONIC VENOUS INSUFFICIENCY." MEDTRONIC VENASEAL WAS USED IN THE PATIENT DESCRIBED IN CASE 3. THE PATIENT UNDERWENT A RIGHT GREAT SAPHENOUS VEIN (GSV) VENASEAL ABLATION FOR C2S DISEASE. THE PATIENT PRESENTED WITH A SMALL HEMATOMA AND RASH AROUND THE PUNCTURE SITE 11 DAYS POST PROCEDURE, WHICH RESOLVED WITH ETERICOXIB AND CHLORPHENIRAMINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537483 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention