BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 23740941 · Received December 8, 2025

    Report

    Report Number
    2183870-2025-00564
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    August 22, 2017
    Report Date
    December 8, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROSPECTIVE COMPARATIVE COHORT STUDY EVALUATING INCOMPETENT GREAT SAPHENOUS VEIN CLOSURE USING RADIOFREQUENCY-POWERED SEGMENTAL ABLATION OR 1470-NM ENDOVENOUS LASER ABLATION WITH RADIAL-TIP FIBERS (VARICO 2 STUDY) OPYRIGHT 2017 BY THE SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER INC. HTTP://DX.DOI.ORG/10.1016/J.JVSV.2017.06.016 JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS JANUARY 2018 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

    BACKGROUND: ENDOVENOUS LASER ABLATION (EVLA) AND RADIOFREQUENCY-POWERED SEGMENTAL ABLATION (RPSA) OF THE INCOMPETENT GREAT SAPHENOUS VEIN (GSV) ARE BOTH KNOWN FOR THEIR EXCELLENT TECHNICAL AND CLINICAL OUTCOMES FOR THE TREATMENT OF VARICOSE VEINS. RPSA HAS REDUCED POSTPROCEDURAL PAIN AND MORBIDITY WITH SHORTER RECOVERY TIME FOR THE PATIENT COMPARED WITH EVLA USING BARE-TIP FIBERS. HOWEVER, NEW-GENERATION EVLA DEVICES WITH LESS TRAUMATIC RADIAL-TIP FIBERS (RTFS) OPERATING AT LONGER WAVELENGTHS UP TO 1470 NM ALSO REDUCE POSTPROCEDURAL PAIN. THE OBJECTIVE OF THIS STUDY WAS TO COMPARE LONG-TERM EFFECTIVENESS OF GSV THERMAL ABLATION AND POSTPROCEDURAL RECOVERY USING RPSA OR 1470-NM EVLA WITH RTF (EVLA-RTF). METHODS: IN A COMPARATIVE PROSPECTIVE MONTHLY ALTERING-TREATMENT COHORT STUDY OF 311 PATIENTS (346 TREATED LEGS), EACH LEG WITH INCOMPETENCE OF THE GSV WAS TREATED WITH EITHER RPSA (158 PATIENTS, 175 LEGS) OR EVL A-RTF (153 PATIENTS, 171 LEGS). THE PRIMARY OUTCOME WAS ANATOMIC OCCLUSION OF THE GSV, ASSESSED AT 12, 24, 36, 48, AND 60 MONTHS USING KAPLAN-MEIER STATISTICS AND COMPARED USING THE LOG-RANK TEST. SECONDARY OUTCOMES INCLUDED FREEDOM OF VARICOSE VEIN RECURRENCE, CL INICAL SUCCESS MEASURED BY VENOUS CLINICAL SEVERITY SCORE (VCSS), DISEASE-SPECIFIC QUALITY OF LIFE DETERMINED USING THE ABERDEEN VARICOSE VEIN QUESTIONNAIRE (AVVQ), POSTOPERATIVE PAIN SCORES, AND TIME TO RETURN TO WORK. RESULTS: THE TOTAL PRIMARY OBLITERATION RATE AFTER 36 AND 60 MONTHS WAS 96.2% WITH RPSA AND 96.7% WITH EVLA-RTF (P ¼ .81). FREEDOM OF SYMPTOMATIC ANTERIOR ACCESSORY VEIN RECURRENCE AFTER 5 YEARS WAS 85% AFTER RPSA AND 87% AFTER EVLA-RTF (P ¼ .50). VCSS AND AVVQ SCORE PRESENTED SIMILAR AND DURABLE IMPROVEMENTS IN BOTH GROUPS BETWEEN 6 WEEKS AND 60 MONTHS. THERE WAS NO DIFFERENCE IN POSTOPERATIVE PAIN SCORES AFTER BOTH TREATMENTS DURING THE FIRST 14 DAYS (MEAN VISUAL ANALOG SCALE SCORE, 0.54-2.19). THE MEDIAN TIME FOR RETURN TO WORK WAS 1 DAY AFTER BOTH TREATMENTS. NO SEVERE ADVERSE EVENTS WERE OBSERVED. CONCLUSIONS: RPSA AND EVLA-RTF HAVE SIMILARLY HIGH GSV OBLITERATION RATES IN THE LONG TERM, AND THE TREATMENTS ARE EQUALLY EFFECTIVE CLINICALLY. BOTH TREATMENTS ARE ASSOCIATED WITH SIMILAR MINIMAL POSTPROCEDURAL PAIN SCORES AND SHORT RECOVERY TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130312 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention