BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 24277819 · Received February 6, 2026

    Report

    Report Number
    2183870-2026-00057
    Event Type
    Injury
    Date Received
    February 6, 2026
    Date of Event
    December 5, 2022
    Report Date
    February 6, 2026
    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

    A RANDOMIZED CLINICAL TRIAL OF ISOLATED AMBULATORY PHLEBECTOMY VERSUS SAPHENOUS THERMAL ABLATION WITH CONCOMITANT PHLEBECTOMY (SAPTAP TRIAL) BJS, 2023, 110, 333¿342 HTTPS://DOI.ORG/10.1093/BJS/ZNAC388. ADVANCE ACCESS PUBLICATION DATE: 5 DECEMBER 2022 RANDOMIZED CLINICAL TRIAL. 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: CURRENT TREATMENT OF PATIENTS WITH SAPHENOUS TRUNK AND TRIBUTARY INCOMPETENCE CONSISTS OF TRUNCAL ABLATION WITH CONCOMITANT, DELAYED OR NO TREATMENT OF THE TRIBUTARY. HOWEVER, REFLUX OF THE SAPHENOUS TRUNK MAY BE REVERSIBLE AFTER TREATMENT OF THE INCOMPETENT TRIBUTARY. THE AIM OF THIS STUDY WAS TO DETERMINE WHETHER SINGLE AMBULATORY PHLEBECTOMY WITH OR WITHOUT DELAYED ENDOVENOUS TRUNCAL ABLATION (SAP) IS NON-INFERIOR TO THERMAL ENDOVENOUS ABLATION WITH CONCOMITANT PHLEBECTOMY (TAP), AND WHETHER SAP IS A COST-EFFECTIVE ALTERNATIVE TO TAP. METHODS: A MULTICENTRE, NON-INFERIORITY RCT WAS CONDUCTED IN PATIENTS WITH AN INCOMPETENT GREAT SAPHENOUS VEIN OR ANTERIOR ACCESSORY SAPHENOUS VEIN WITH ONE OR MORE INCOMPETENT TRIBUTARIES. PARTICIPANTS WERE RANDOMIZED TO RECEIVE SAP OR TAP. AFTER 9 MONTHS, ADDITIONAL TRUNCAL TREATMENT WAS CONSIDERED FOR SAP PATIENTS WITH REMAINING SYMPTOMS. THE PRIMARY OUTCOME WAS VENOUS INSUFFICIENCY EPIDEMIOLOGICAL AND ECONOMIC STUDY QUALITY OF LIFE/SYMPTOMS (VEINES-QOL/SYM SCORE) AFTER 12 MONTHS. SECONDARY OUTCOMES WERE, AMONG OTHERS, COST-EFFECTIVENESS, PERCEIVED IMPROVEMENT OF SYMPTOMS, AND ANATOMICAL SUCCESS. RESULTS: SOME 464 PATIENTS RECEIVED THE ALLOCATED TREATMENT (SAP 227, TAP 237). VEINES-QOL SCORES WERE 52.7 (95 PER CENT C.I. 51.9 TO 53.9) FOR SAP AND 53.8 (53.3 TO 55.1) FOR TAP; VEINES-SYM SCORES WERE 53.5 (52.6 TO 54.4) AND 54.2 (54.0 TO 55.6) RESPECTIVELY. FIFTY-EIGHT PATIENTS (25.6PER CENT) IN THE SAP GROUP RECEIVED ADDITIONAL TRUNCAL ABLATION. TREATMENT WITH SAP WAS LESS COSTLY THAN TREATMENT WITH TAP. CONCLUSION: ONE YEAR AFTER TREATMENT, PARTICIPANTS WHO UNDERWENT SAP HAD NON-INFERIOR HEALTH-RELATED QUALITY OF LIFE COMPARED WITH THOSE WHO HAD TAP. TREATMENT WITH SAP WAS A COST-EFFECTIVE ALTERNATIVE TO TAP AT 12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341885 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention