BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 23264511 · Received October 10, 2025

    Report

    Report Number
    2183870-2025-00482
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    July 22, 2025
    Report Date
    October 10, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPARISON OF RADIOFREQUENCY ABLATION AND HIGH LIGATION STRIPPING FOR VARICOSE VEINS: A RETROSPECTIVE ANALYSIS ANN VASC SURG 2025; 120: 392¿399 HTTPS://DOI.ORG/10.1016/J.AVSG.2025.07.025 2025 ELSEVIER INC A2 AVERGAE 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

    BACKGROUND: TO COMPARE THE CLINICAL EFFICACY, POSTOPERATIVE COMPLICATIONS, AND QUALITY-OFLIFE (QOL) OUTCOMES OF ULTRASOUND-GUIDED RA DIOFREQUENCY ABLATION (RFA) COMBINED WITH TRIBUTARY PHLEBECTOMY AND FOAM SCLEROTHERAPY VERSUS HIGH LIGATION AND STRIPPING (HLS) COMBINED WITH TRIBUTARY PHLEBECTOMY. METHODS: WE RETROSPECTIVELY ANALYZED 2,740 PATIENTS (1,588 WOMEN; MEAN AGE 59.01 ± 12.03 YEARS) TRE ATED BETWEEN (B)(6) 2020 AND (B)(6) 2023. AMONG THEM, 1,756 (64.1%) UNDERWENT RFA AND 984 (35.9%) UNDERWENT HLS. WE ASSESSED IMMEDIATE SUCCESS RATE, 12-MONTH RECANALIZATION, SYMPTOMATIC RECURRENCE, REINTERVENTION RATE, AND COMPLICATIONS; THE ABERDEEN VARICOSE VEIN QUESTIONNAIRE (AVVQ) AND CHRONIC VENOUS INSUFFICIENCY QUALITY OF LIFE QUESTIONNAIRE (CIVIQ-14) SCORES WERE USED TO EVALUATE QOL, WHILE THE VENOUS CLINICAL SEVERITY SCORE (VCSS) WAS USED TO ASSESS DISEASE SEVERITY AT 1, 6, AND 12 MONTHS POSTOPERATIVELY. RESULTS: IMMEDIATE SUCCESS WAS ACHIEVED IN BOTH GROUPS. AT 12 MONTHS, THE RFA GROUP HAD 7 RECANALIZATIONS (0.40%) VERSUS 0 IN THE HLS GROUP (P ¼ 0.112); SYMPTOMATIC RECURRENCE WAS 0.17% VERSUS 0.20% (P ¼ 1.000); REINTERVENTION RATE WAS 2.62% VERSUS 3.05% (P ¼ 0.064); ANDEACH GROUP HAD 2 CASES OF DEEP VEIN THROMBOSIS. MINOR COMPLICATIONS IN THE HLS GROUP INCLUDED BRUISING (25.20% VS. 20.16%, P ¼ 0.002), PAIN (25.41% VS. 20.39%, P ¼ 0.002), AND NUMBNESS (10.98% VS. 3.30%, P <(><<)> 0.001); THE RFA GROUP HAD HIGHER INDURATION (17.20% VS. 3.25%, P 0.001) AND PIGMENTATION (2.62% VS. 0.81%, P ¼ 0.001). BOTH GROUPS SHOWED SIGNIFICANT IMPROVEMENTS IN AVVQ, VCSS, AND CIVIQ-14 SCORES (P 0.05), WITH THE RFA GROUP DEMONSTRATING GREATER EARLY IMPROVEMENT AT 1 MONTH. CONCLUSION: ULTRASOUND-GUIDED RFA WITH FOAM SCLEROTHERAPY REDUCES MINOR COMPLICATIONS SUCH AS PAIN, BRUISING, AND NUMBNESS AND SIGNIFICANTLY IMPROVES EARLY QOL, THOUGH IT CARRIES A HIGHER RISK OF INDURATION AND PIGMENTATION. BOTH RFA AND HLS OFFER GOOD LONG-TERM EFFICACY AND LOW RECURRENCE RATES; TREATMENT SHOULD BE INDIVIDUALIZED BASED ON PATIENT CONDITION AND RECOVERY NEEDS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311997 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention