BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 23448652 · Received November 3, 2025

    Report

    Report Number
    2183870-2025-00503
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    January 14, 2019
    Report Date
    November 3, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE TITLE TWELVE-MONTH EFFICACY AND COMPLICATIONS OF CYANOACRYLATE EMBOLIZATION COMPARED WITH RADIOFREQUENCY ABLATION FOR INCOMPETENT GREAT SAPHENOUS VEINS COPYRIGHT 2018 BY THE SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER INC. HTTPS://DOI.ORG/10.1016/J.JVSV.2018.10.019 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: IN THIS STUDY, THE CLINICAL RESULTS OF RADIOFREQUENCY ABLATION (RFA) AND N-BUTYL-CYANOACRYLATE EMBOLIZATION (CAE) METHODS WERE COMPARED IN THE TREATMENT OF INCOMPETENT GREAT SAPHENOUS VEINS (GSVS). METHODS: WE ANALYZED RETROSPECTIVELY 244 PATIENTS (128 PATIENTS IN THE RFA GROUP, 116 PATIENTS IN THE CAE GROUP) WITH INCOMPETENT GSVS WHO WERE TREATED WITH RFA AND CAE ACCORDING TO THE PATIENTS¿ CHOICE BETWEEN (B)(6) 2016. ALL PATIENTS WERE THOROUGHLY EXAMINED PREOPERATIVELY AND AT 1, 3, 6, AND 12 MONTHS AFTER THE OPERATION, AND THE CLINICAL RESULTS AND THE QUALITY OF LIFE WERE EVALUATED. COLOR DOPPLER ULTRASOUND (CDUS) RESULTS WERE COMPARED BETWEEN TWO GROUPS AFTER THE OPERATION AND AT 12 MONTHS. COMPLETE VEIN OCCLUSION WAS DEFINED AS THE SUCCESS OF THE TREATMENT. RESULTS: THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN PATIENTS TREATED WITH RFA OR CAE IN TERMS OF DEMOGRAPHIC AND CLINICAL FEATURES. IN CDUS AFTER OPERATION, TOTAL OCCLUSION WAS DETECTED IN THE SAPHENOUS VEIN IN BOTH GROUPS. AT THE 12-MONTH CDUS, COMPLETE OCCLUSION OF THE GSV WAS OBSERVED IN 99.5% OF THE CAE GROUP AND 96.6% OF THE RFA GROUP (P ¼ .072). SKIN BURN, WHICH WE CONSIDER A MAJOR COMPLICATION, OCCURRED ONLY IN ONE PATIENT. NO OTHER MAJOR COMPLICATIONS WERE SEEN IN EITHER GROUP. SEVERE PAIN, ECCHYMOSIS, AND SENSITIVITY WERE THE MOST COMMON OF THE SIDE EFFECTS, AND THESE WERE SIGNIFICANTLY HIGHER IN RFA GROUP THAN IN CAE GROUP. SEVERE PAIN OCCURRED IN 12.5% OF THE RFA PATIENTS AND 4.3% OF THE CAE PATIENTS (P ¼ .042), ECCHYMOSIS OCCURRED IN 20.3% OF THE RFA PATIENTS AND 12% OF THE CAE PATIENTS (P ¼ .044), AND SENSITIVITY OCCURRED IN 21.9% OF THE RFA PATIENTS AND 12.1% OF THE CAE PATIENTS (P ¼ .038), RESPECTIVELY. CONCLUSIONS: BASED ON THE PRESENT DATA, OUR FINDINGS SUGGEST THAT CAE IS AS EFFECTIVE AS RFA ABLATION WITH SIMILAR RATES OF SUCCESSFUL OCCLUSION AND CAN BE ASSOCIATED WITH LESS PAIN AND FEWER COMPLICATIONS THAN RFA; IT ALSO MAY YIELD BETTER PATIENT COMFORT. THE CURRENT RESULTS SHOULD BE VERIFIED WITH FURTHER RANDOMIZED, CONTROLLED TRIALS WITH LONGER TERM FOLLOWUP AND LARGER PATIENT GROUPS. (J VASC SURG: VENOUS AND LYM DIS 2019;7:210-6.).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054332 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention