BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 24018041 · Received January 9, 2026

    Report

    Report Number
    2183870-2026-00010
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    March 31, 2025
    Report Date
    January 9, 2026
    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

    EARLY OUTCOMES OF THE THIRD GENERATION OF CLOSUREFAST RADIOFREQUENCY ABLATION FOR GREAT SAPHENOUS VEIN REFLUX VASA (2025), 54 (4), 280¿286 2025 HOGREFE HTTPS://DOI.ORG/10.1024/0301-1526/A001195 D. BACCELLIERI ET AL., EARLY OUTCOMES WITH LAST CLOSUREFAST ABLATION SYSTEM 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

    SUMMARY: BACKGROUND: THIS STUDY AIMED TO ASSESS THE SAFETY OF THE THIRD-GENERATION CLOSUREFAST CATHETER FOR RADIOFREQUENCY ABLATION (RFA) IN THE TREATMENT OF GREAT SAPHENOUS VEIN (GSV) REFLUX IN PATIENTS PRESENTING TO A DEDICATED VEIN CENTER. MATERIALS AND METHODS: ALL CONSECUTIVE PATIENTS WITH INCOMPETENT GSV WHO UNDERWENT RFA BETWEEN DECEMBER 2023 AND MAY 2024 WERE RETROSPECTIVELY ANALYZED. THE PRIMARY STUDY ENDPOINTS WERE TECHNICAL SUCCESS AND POSTOPERATIVE COMPLICATION RATE AT 30 DAYS. SECONDARY STUDY ENDPOINTS WERE FREEDOM FROM GSV RECANALIZATION AND RECURRENT VARICOSE VEIN (RVV) RATE OVER THE FOLLOW-UP. THE IMPROVEMENT IN SYMPTOMS (MEASURED BY THE VENOUS CLINICAL SEVERITY SCORE [VCSS]) WAS EVALUATED. RESULTS: DURING THE STUDY PERIOD, 50 LIMBS WERE TREATED IN 50 CONSECUTIVE PATIENTS (MEAN AGE 55.8±13.4 YEARS; 56% WOMEN; CEAP 2-4; VCSS >5). THE TECHNICAL SUCCESS RATE WAS ACHIEVED IN 100% OF CASES. THERE WAS NO SIGNIFICANT INCIDENCE OF 30-DAY COMPLICATIONS. THERE WERE NO INSTANCES OF DEEP VENOUS THROMBOSIS OR PUNCTURE SITE THERMAL INJURY. ONE PATIENT (2%) HAD HYPERPIGMENTATION; TWO PATIENTS (4%) HAD ECCHYMOSIS; 4 PATIENTS (8%) HAD PAIN. AT A MEAN FOLLOW-UP OF 2.9±1.4 MONTHS, GSV OCCLUSION AND FREEDOM FROM REINTERVENTION RATES WERE BOTH 100% WITHIN 1 WEEK AND 30 DAYS RESPECTIVELY. NO PATIENTS HAD RVV OVER THE FOLLOW-UP. THE VCSS SCORE HAD DECREASED A MEDIAN OF 3.5 (IQR: 2.4¿5) POINTS FROM BASELINE. THE MEAN CEAP CLASS HAD DECREASED TO 1.59 POINTS FROM BASELINE, REFLECTING A SHIFT TOWARDS MILDER DISEASE CATEGORIES (C0¿C2). CONCLUSIONS: THE THIRD GENERATION OF RFA IS SAFE AND EFFECTIVE TO ABLATE THE GSV WITH A LOW COMPLICATION RATE IN THE PERIOPERATIVE PERIOD. HOWEVER, DURABILITY OVER THE FOLLOW-UP AND FURTHER STUDIES WITH LARGER COHORTS OF PATIENTS ARE STILL NEEDED TO CONFIRM THESE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81792 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention