BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 23486967 · Received November 6, 2025

    Report

    Report Number
    9610849-2025-00093
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    July 24, 2019
    Report Date
    November 6, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE TITLE A RANDOMISED CONTROLLED TRIAL COMPARING THREE DIFFERENT RADIOFREQUENCY TECHNOLOGIES: SHORT-TERM RESULTS OF THE 3-RF TRIAL EUR J VASC ENDOVASC SURG (2019) 58, 401E408 TWITTER: ISAACNYAMEKYE@VEINDOC1 1078-5884/ 2019 EUROPEAN SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER B.V. ALL RIGHTS RESERVED. HTTPS://DOI.ORG/10.1016/J.EJVS.2019.01.033 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

    OBJECTIVE: TO DATE THERE HAS BEEN NO COMPARISON OF OUTCOMES OF ENDOVENOUS RADIOFREQUENCY (RF) DEVICES. THE 3-RF TRIAL IS THE FIRST R ANDOMISED CONTROLLED TRIAL OF THREE COMMERCIALLY AVAILABLE RF ABLATION TECHNOLOGIES. METHODS: THREE HUNDRED AND TWO PATIENTS WERE ASSESSED AND 187 PATIENTS, SELECTED FOR THEIR NON-TORTUOUS VEINS, WERE ENROLLED. ONE HUNDRED AND EIGHTY-TWO PATIENTS WERE RANDOMISED BETWEEN SEPTEMBER 2014 AND SEPTEMBER 2016. PATIENTS WERE RECRUITED [182/302 PATIENTS WITH GREAT SAPHENOUS VEIN (GSV) INCOMPETENCE] INTO A PROSPECTIVE DOUBLE BLIND RANDOMISED TRIAL OF VENEFIT, RADIOFREQUENCY INDUCED THERMAL THERAPY (RFITT), AND ENDOVENOUS RADIOFREQUENCY (EVRF). THE PRIMARY OUTCOME MEASURE WAS GSV CLOSURE (TOTAL/PARTIAL/FAILED) AT SIX MONTHS. SECONDARY OUTCOME MEASURES INCLUDED ABLATION TIMES, COMPLICATIONS, PAIN SCORES, ANALGESIA REQUIREMENTS, AND QUALITY OF LIFE (QOL) SCORES TO 12 MONTHS. RESULTS: PATIENTS TREATED [180: VENEFIT (57), RFITT (64), EVRF (59)] WERE MATCHED FOR AGE, SEX, AND VEIN CHARACTERISTICS. AT SIX MONTHS, COMPLETE GSV CLOSURE WAS SIGNIFICANTLY BETTER AFTER VENEFIT AND RFITT TREATMENT (100% AND 98%, RESPECTIVELY) COMPARED WITH EVRF TREATMENT (79%, P / .001). MEAN TREATMENT TIME WAS SIGNIFICANTLY FASTER FOR RFITT THAN FOR VENEFIT AND EVRF (P /.0001). EUROQOL 5D (EQ5D) VISUAL ANALOGUE SCORE (VAS) DID NOT DIFFER BETWEEN GROUPS AT ANY TIME POINT. THE ONLY DIFFERENCE BETWEEN GROUPS IN EQ5D DOMAIN SCORES WAS FOR THE PAIN/DISCOMFORT DOMAIN AT TWO WEEKS WHEN SIGNIFICANTLY FEWER EVRF PATIENTS REPORTED NO PROBLEMS COMPARED WITH VENEFIT AND RFITT. THIS DIFFERENCE HAD DISAPPEARED AT SIX AND 12 MONTHS. THE ABERDEEN VARICOSE VEIN QUESTIONNAIRE (AVVQ) IMPROVED FOR ALL GROUPS AT SIX AND 12 MONTHS COMPARED WITH PRE-TREATMENT LEVELS; HOWEVER, THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN GROUPS. NO PATIENTS DEVELOPED DEEP VENOUS THROMBOEMBOLISM, SKIN BURNS, WOUND INFECTIONS, POST-OPERATIVE PARAESTHESIA, OR SKIN DISCOLOURATION. ONE PATIENT DEVELOPED ASYMPTOMATIC ENDOVENOUS HEAT INDUCED THROMBOSIS (EHIT) GRADE 2 FOLLOWING EVRF TREATMENT. THIS INCIDENTAL FINDING ON TWO WEEK DUPLEX IMAGING WAS MANAGED CONSERVATIVELY (WITHOUT ANY ADDITIONAL MEDICATION) AND HAD RESOLVED WITHOUT INCIDENT ON THE SIX-MONTH IMAGING. CONCLUSION: COMPARED WITH VENEFIT AND RFITT, EVRF WAS ASSOCIATED WITH SIGNIFICANT FAILURE OF TRUNCAL ABLATION AT SIX MONTHS; HOWEVER, CLINICAL OUTCOMES DID NOT DIFFER SIGNIFICANTLY AT 12 MONTHS. NO PATIENTS DEVELOPED DEEP VENOUS THROMBOEMBOLISM, SKIN BURNS, WOUND INFECTIONS, POST-OPERATIVE PARAESTHESIA, OR SKIN DISCOLOURATION. ONE PATIENT DEVELOPED ASYMPTOMATIC ENDOVENOUS HEAT INDUCED THROMBOSIS (EHIT) GRADE 2 FOLLOWING EVRF TREATMENT. THIS INCIDENTAL FINDING ON TWO WEEK DUPLEX IMAGING WAS MANAGED CONSERVATIVELY (WITHOUT ANY ADDITIONAL MEDICATION) AND HAD RESOLVED WITHOUT INCIDENT ON THE SIX-MONTH IMAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2637892 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention