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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hematoma (1884); 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.297 patients were included in the study of which 218 patients were prescribed rivaroxaban, and 79 were prescribed enoxaparin for vte prophylaxis.In total, 333 great saphenous vein (gsv) trunks and 42 short saphenous vein (ssv) trunks were obliterated.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 prima ry 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 hemoglobin 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.Clinical events of endovenous heat-induced thrombosis (ehit) grade 2-4, vein recanalization at 12 months and crnm bleeding are reported.Hematoma in the zone of miniphlebectomy, which required an additional draining and was classified as crnm bleeding.The patients where ehit was observed were switched to rivaroxaban of 20 mg once daily for three weeks with full resorption of thrombotic masses in the common femoral vein.No other aes potentially attributed to rivaroxaban or enoxaparin were documented in the medical records.No other adverse events are reported.

• Brand Name: CLOSUREFAST CATHETER
• Type of Device: 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12031315
• MDR Text Key: 257121523
• Report Number: 2183870-2021-00223
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K111887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2021

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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR