BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 24290254 · Received February 9, 2026

    Report

    Report Number
    2183870-2026-00058
    Event Type
    Injury
    Date Received
    February 9, 2026
    Date of Event
    May 15, 2024
    Report Date
    February 9, 2026
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL OUTCOMES OF NONTHERMAL ABLATION, THERMAL ABLATION, AND SURGICAL STRIPPING FOR VARICOSE VEINS 2024 THE AUTHOR(S). PUBLISHED BY ELSEVIER INC. ON BEHALF OF THE SOCIETY FOR VASCULAR SURGERY. (HTTP://CREATIVECOMMONS.ORG/LICENSES/BY-NC-ND/4.0/). HTTPS://DOI.ORG/10.1016/J.JVSV.2024.101902 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 OBJECTIVE: THE PURPOSE OF THIS STUDY WAS TO COMPARE THE CLINICAL OUTCOMES OF RADIOFREQUENCY ABLATION (RFA), CYANOACRYLATE C LOSURE (CAC), MECHANOCHEMICAL ABLATION (MOCA), AND SURGICAL STRIPPING (SS) FOR INCOMPETENT SAPHENOUS VEINS AND TO DETERMINE A SUITABLE TREATMENT MODALITY FOR A SPECIFIC CLINICAL SITUATION. METHODS: WE RETROSPECTIVELY REVIEWED THE DATA OF PATIENTS WITH VARICOSE VEINS WHO UNDERWENT RFA, CAC, MOCA, OR SS FROM JANUARY 2012 TO JUNE 2023. THE CLINICAL OUTCOMES, INCLUDING POSTOPERATIVE COMPLICATIONS AND THE ABERDEEN VARICOSE VEIN QUESTIONNAIRE SCORE, WERE ASSESSED. RESULTS: DURING THE STUDY PERIOD, 2866 PATIENTS WITH VARICOSE VEINS WERE TREATED. AMONG THEM, 1670 PATIENTS (57.9%) WERE WOMEN. THE MEAN AGE WAS 55.3 6 12.9 YEARS. RFA, CAC, MOCA, AND SS WERE PERFORMED IN 1984 (68.7%), 732 (25.4%), 78 (2.7%), AND 88 (3.0%) PATIENTS, RESPECTIVELY. THE COMPLETE TARGET VEIN CLOSURE RATE AFTER RFA, CAC, AND MOCA WAS 94.5%, 98%, AND 98%, RESPECTIVELY. THE ABSENCE OF A TARGET VEIN AFTER SS WAS 98%. DEEP VEIN THROMBOSIS DEVELOPED IN FOUR PATIENTS: ONE IN THE RFA GROUP AND THREE IN CAC GROUP. SURGICAL OR ENDOVENOUS PROCEDURE-INDUCED THROMBOSIS OCCURRED IN 2.3%, 4.8%, 6.4%, AND 2.3% OF THE PATIENTS AFTER RFA, CAC, MOCA, AND SS, RESPECTIVELY. PHLEBITIS ALONG THE TARGET VEIN OCCURRED IN 0.2% AND 3.8% OF PATIENTS AFTER RFA AND MOCA, RESPECTIVELY. A HYPERSENSITIVITY REACTION OCCURRED IN 3.7% OF PATIENTS AFTER CAC. READMISSION WAS REQUIRED FOR TWO PATIENTS WHO HAD UNDERGONE SS. TRANSIENT NERVE SYMPTOMS DEVELOPED IN FIVE (0.3%), ZERO, ONE (1.3%), AND TWO (2.3%) PATIENTS AFTER RFA, CAC, MOCA, AND SS, RESPECTIVELY. AFTER TREATMENT, THE ABERDEEN VARICOSE VEIN QUESTIONNAIRE SCORE IMPROVED SIGNIFICANTLY IN ALL GROUPS. CONCLUSIONS: THE CLINICAL OUTCOMES WITH IMPROVEMENT IN QUALITY OF LIFE WERE COMPARABLE AMONG THE DIFFERENT TREATMENT MODALITIES. THE PROXIMITY OF THE NERVE OR SKIN TO THE TARGET VEIN IS THE MOST IMPORTANT FACTOR IN SELECTING A SUITABLE TREATMENT MODALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351422 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention