BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 23742432 · Received December 8, 2025

    Report

    Report Number
    2183870-2025-00567
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    July 20, 2023
    Report Date
    December 8, 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 OXYBUPROCAINE AND LIDOCAINE TOPICAL ANESTHESIA FOR PAIN CONTROL IN RADIOFREQUENCY ABLATION TREATMENT OF GREAT SAPHENOUS VEIN INSUFFICIENCY YAN ET AL. MEDICINE (2023) 102:34 HTTP://DX.DOI.ORG/10.1097/MD.0000000000034688 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 TOPICAL ANESTHETICS HAVE BEEN USED FOR RADIOFREQUENCY ABLATION OF GREAT SAPHENOUS VEIN INSUFFICIENCY. A TOTAL OF 74 PATIENTS WITH GREAT SAPHENOUS VEIN INSUFFICIENCY TREATED AT OUR CENTER BETWEEN FEBRUARY 2021 AND AUGUST 2022 WERE ENROLLED. THE PATIENTS WERE SELECTED AND DIVIDED INTO AN OXYBUPROCAINE GROUP(N = 30) AND A LIDOCAINE GROUP (N = 44). THE VISUAL ANALOGUE SCALE (VAS) WAS USED TO EVALUATE INTRAOPERATIVE AND POSTOPERATIVE PAIN. PATIENT SATISFACTION WITH ANESTHESIA, MAINTENANCE TIME OF ANESTHESIA, AND DISTURBANCE OF THE SURGEONS WERE ALSO RECORDED AND ASSESSED. THE VAS SCORES AND OTHER INDICES OF THE 2 GROUPS WERE COMPARED TO ASSESS THE EFFECTIVENESS OF ANESTHESIA. PERIOPERATIVE SURGICAL COMPLICATIONS AND PAINKILLER USE WERE ALSO RECORDED. THE MEDIAN VAS SCORE OF THE PATIENTS DURING THE PROCESS WAS 2 IN BOTH GROUPS, AND THE DIFFERENCE BETWEEN THE GROUPS WAS NOT STATISTICALLY SIGNIFICANT. IN THE 2 GROUPS, 93.33% OF THE PATIENTS IN THE OXYBUPROCAINE GROUP AND 93.18% OF THE PATIENTS IN THE LIDOCAINE GROUP WERE SATISFIED WITH THE ANESTHESIA. NINE PATIENTS IN THE LIDOCAINE GROUP AND 14 IN THE OXYBUPROCAINE GROUP RECEIVED ADDITIONAL ANESTHETIC DRUGS. THE AVERAGE MAINTENANCE TIME OF ANESTHESIA WAS LONGER IN THE LIDOCAINE GROUP. NO SERIOUS COMPLICATIONS OCCURRED IN EITHER OF THE GROUPS. BOTH OXYBUPROCAINE AND LIDOCAINE TOPICAL ANESTHESIA COMBINED WITH TUMESCENT ANESTHESIA COULD PROVIDE EFFECTIVE PAIN CONTROL IN RADIOFREQUENCY ABLATION TREATMENT OF GREAT SAPHENOUS VEIN INSUFFICIENCY. ALTHOUGH THE AVERAGE MAINTENANCE TIME OF ANESTHESIA WAS LONGER IN THE LIDOCAINE GROUP, THERE WAS NO DIFFERENCE IN THE ASSOCIATED COMPLICATIONS AND PAIN CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157324 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention