BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 23875678 · Received December 23, 2025

    Report

    Report Number
    2183870-2025-00596
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    January 4, 2022
    Report Date
    December 23, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QUALITY-OF-LIFE ASSESSMENT IN PATIENTS TREATED WITH RADIOFREQUENCY ABLATION WITH OR WITHOUT GREAT SAPHENOUS VEIN RECANALIZATION PHLEBOLOGY 2022, VOL. 37(3) 223¿225 © THE AUTHOR(S) 2022 ARTICLE REUSE GUIDELINES: SAGEPUB.COM/JOURNALS-PERMISSIONS DOI: 10.1177/02683555211060622 JOURNALS.SAGEPUB.COM/HOME/PHL A2 AVERAGE AGE A3 MAJORITY GENDER B3 DATE OF PUBLICATION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ABSTRACT QUALITY OF LIFE (QOL) IN PATIENTS WITH CHRONIC VENOUS DISORDERS HAS A CENTRAL ROLE TO DECIDE THE CORRECT TREATMENT APPROACH. IN PARTICULAR, IN CASE OF MINI-INVASIVE THERAPY, SUCH AS ENDOVENOUS RADIOFREQUENCY ABLATION (RFA), THE POSTOPERATIVE QOL IMPROVEMENT REMAINS ONE OF THE MOST IMPORTANT OUTCOMES TO BE REACHED. DESPITE THIS, VERY FEW DATA ARE PUBLISHED ON THE LONG-TERM QOL MODIFICATIONS AFTER RFA. THE AIM OF THIS BRIEF REPORT IS TO DESCRIBE AND ANALYZE THE ROLE OF QOL SCALES IN A POPULATION OF PATIENTS TREATED WITH RFA OF THE GREAT SAPHENOUS VEIN AND PHLEBECTOMIES, HIGHLIGHTING RESULTS IN SHORT- AND LONG-TERM FOLLOW-UP PERIOD, AND DIFFERENCES BETWEEN RECANALIZED AND NON-RECANALIZED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2703216 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown