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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ecchymosis (1818); Phlebitis (2004); Thrombosis/Thrombus (4440)

Event Date 04/18/2022

Event Type  Injury  

Event Description

Background: endovenous thermal ablation (evta) is the second-generation treatment of varicose veins in the lower extremities.It has overcome the shortcomings of the first-generation treatment of high ligation and stripping.Further, it is the basis for the development of the third-generation treatment with endovenous glue ablation.It is currently recommended as the first-line treatment for varicose veins accompanied by great saphenous vein incompetence.Closure fast device was reported in the literature article current concepts: evta involves obliterating the varicosed veins by applying thermal energy to blood or vein wall.It can be performed by laser or radiofrequency ablation methods, under local anesthesia.The treatment results are excellent and show lesser pain and faster recovery compared to the first-generation treatment.However, complications include endovenous heat-induced thrombosis, deep vein thrombosis, ecchymosis, and phlebitis.Discussion and conclusion: to enhance the therapeutic effect and reduce the complications of evta, sufficient tumescent anesthesia, a controlled number of firing in radiofrequency ablation, and use of the novel high wavelength laser and a radial catheter tip in endovenous laser ablation are recommended.In addition, proficiency in other generations of varicose vein treatments could help in various situations.

Manufacturer Narrative

Literature title: second-generation treatment of varicose veins: endovenous thermal ablation by laser or radiofrequency ablation (b)(6) 2022; 65(4):209-216.Date of event: date of acceptance.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
• 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: 14641962
• MDR Text Key: 293653280
• Report Number: 2183870-2022-00197
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K111887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• 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: 06/02/2022
• 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