MAUDE Adverse Event Report: COVIDIEN CLOSUREFAST CATHETER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ecchymosis (1818); Hemorrhage/Blood Loss/Bleeding (1888); Vasculitis (2004); Thrombosis/Thrombus (4440)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Objective: to compare early and two-year results for n-butyl cyanoacrylate (nbca), radiofrequency ablation (rfa), and endovenous las er ablation (evla) in the treatment of varicose veins.Methods: this was a randomised clinical trial.Five hundred and twenty-five patients were blindly randomised into nbca, rfa, and evlt groups (175 patients to each group; block randomisation using sealed envelopes).Four hundred and fifty-six patients were monitored for 2 years (ultrasound at 2 days, and 6, 12, and 24 months).The primary endpoint was the saphenous vein occlusion rates, and the secondary endpoints were peri- and postprocedural pain, complications, and time to return to work.No simultaneous phlebectomies were performed.Results: the numbers of patients lost to follow up were nbca seven, rfa 26, and evla 36.Occlusion rates were similar at 6, 12, and 24 months (6 months [nb 98.1%, rfa 94.1%, and evla 95.1%, p =.14], 1 year [nbca 94.7%, rfa 92.5%, and evla 94.2%, =.72], 2 years [nbca 92.6%, rfa 90.9%, and evla 91.5%, =.89]).Peri-procedural pain was significantly lower after nbca (p.001), but complication rates (dvt, bleeding, and phlebitis) were similar.Time to return to work was shortest after nbca (nbca 1.04 days, rfa 1.56 days and evla 1.31 days (p.001) with 95% (nbca), 50% (rfa) and 75% (evla) of patients returning to work on day 1.Pre-procedural venous clinical severity scores (vcsss) were the same in all groups.A decrease was observed in vcss values in all groups at 6 months, and this persisted at 1 and 2 years.However, vcss scores at 6 months and 2 years were significantly lower in the nbca group (p.001).Foam sclerotherapy was subsequently applied to varicosetributaries in 18 patients from all groups.Conclusion: no differences were observed in occlusion rates between the three modalities, but nbca appeared superior with respect to peri-procedural pain, return to work and decreased vcss.

• Brand Name: CLOSUREFAST CATHETER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24739880
• Report Number: 2183870-2026-00145
• Device Sequence Number: 8879161
• Product Code: GEI
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K111887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/31/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female