BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 12513026 · Received September 22, 2021

    Report

    Report Number
    2183870-2021-00350
    Event Type
    Injury
    Date Received
    September 22, 2021
    Date of Event
    May 8, 2020
    Report Date
    February 3, 2022
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    RECURRENCE RATES AND FORM OF RECURRENCE AFTER ENDOLUMINAL ABLATION OF THE GREAT SAPHENOUS VEIN PHLEBOLOGY (2020) 49: 222¿230 10.1055/A-1033-2736. AVERAGE AGE. MAJORITY GENDER. EVENT DATE: DATE OF ARTICLE PUBLICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A RETROSPECTIVE COMPARATIVE STUDY ON THE OCCLUSION RATE OF INSUFFICIENCY VSM WAS CARRIED OUT IN 297 PATIENTS. CLOSUREFAST ABLATION DEVICE WAS ONE OF THE DEVICES USED IN THE STUDY WITH 94 PATIENTS TREATED WITH THE DEVICE. ALL PATIENTS WERE OPERATED ON UNDER TUMESCENT LOCAL ANESTHESIA (TLA), DEPENDING ON THE PATIENT'S WISHES OR SEVERITY OF LATERAL ADESTAL VARICOSE VEIN COMBINED WITH ANALGOSEDATION OR INTUBATION ANESTHESIA. ACCORDING TO THE STUDY PROTOCOL, THE FOLLOW-UP CHECKS TOOK PLACE 14 DAYS, 3 MONTHS AND 1 YEAR POSTOPERATIVELY AND THEN ANNUALLY. 95% FUNCTIONAL SUCCESS WAS REPORTED FOR CLOSUREFAST TREATMENT AT FOLLOW UP. DEEP VEIN THROMBOSIS OCCURRED IN ONE OF THE PATIENTS TREATED WITH THE DEVICE. OTHER PATIENTS EXPERIENCED ECCHYMOSIS, HYPERPIGMENTATION, PAIN AND SENSITIVITY DISORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411164 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention