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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/21/2021

Event Type  Injury  

Manufacturer Narrative

Journal article title: rivaroxaban for the prevention of venous thromboembolism after radiofrequency ablation of saphenous veins con comitant with miniphlebectomy, sclerotherapy, or no treatment of varicose tributaries phlebology 0(0) 1¿11 ! the author(s) 2021 article reuse guidelines: sagepub.Com/journals-permissions doi: 10.1177/02683555211017336 journals.Sagepub.Com/home/phl.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study to assess the efficacy and safety of once-daily 10 mg rivaroxaban for venous thromboembolism prophylaxis (vte) after closurefast radiofrequency ablation (rfa) of saphenous veins.Medtronic¿s closurefast catheter was used for treatment.The author reports that the local protocol for rfa with closurefast has some differences from the international protocols and manufacturer¿s instruction.The catheter is placed more closely to the junction (2 cm in contrast to recommended 3 cm) and perform more heating cycles for significantly dilated veins (three cycles at the junction and one to three cycles along the trunk in comparison with two cycles at the junction and one cycle along the trunk).The rationale is based on the previously published experimental data suggesting that the depth of vein wall injury depends on the number of cycles and three cycles that damage all layers.Tumescent anaesthesia under ultrasound guidance was used.The truncal ablation could be supplemented by simultaneously miniphlebectomy or sclerotherapy.The primary efficacy endpoint of the study was designed as a combination of ehit (grade of 2¿4), any symptomatic or asymptomatic dvt, and symptomatic pe within the first month after the intervention.The primary safety endpoint was designed as a combination of major and clinically relevant non-major (crnm) bleeding defined as fatal bleeding, and/or symptomatic bleeding in the critical area (intracranial, intraspinal, intraocular, retroperitoneal, pericardial, in a non-operated joint, or intramuscular with compartment syndrome), and/or extrasurgical site bleeding causing a fall in hemoglo bin level or leading to transfusion of two or more units of whole blood or red cells, and/or surgical site bleeding that requires a second intervention of sufficient size to delay mobilization or wound healing, to prolong hospitalization or to result in deep wound infection, and/or surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability within the first month after the intervention.One patient in the enoxaparin group developed ehit classified as grade 2 as detected by dus on the next day after gsv ablation.The patient was switched to rivaroxaban of 20 mg once daily for three weeks with full resorption of thrombotic massesin the common femoral vein.No other adverse event is reported.

Manufacturer Narrative

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.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.

• Brand Name: CLOSUREFAST CATHETER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 12031308
• MDR Text Key: 257121277
• Report Number: 2183870-2021-00222
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K111887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention