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

Device Problem No Apparent Adverse Event (3189)

Patient Problems Unspecified Infection (1930); Ulcer (2274); Impaired Healing (2378)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

Event date reflects article published date.A comparison of cyanoacrylate glue and radiofrequency ablation techniques in the treatment of superficial venous reflux in ceap 6 patients journal of vascular surgery: venous and lymphatic disorders (2021) 9(5):1215-1221 10.1016/j.Jvsv.2020.12.082.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study which compared the rates of venous wound healing between two techniques of superficial vein closure, venaseal and closurefast.A retrospective review was performed of patients who had undergone closure of truncal veins within a 5-year defined time.119 patients were included in the study.119 limbs treated where 68 were treated with closurefast and 51 with venaseal.The technical success rate was 100% for all veins ablated as confirmed by the post-procedure duplex ultrasound examination.No device-related complications were reported.No postoperative dvts occurred in our patient cohort.Wound healing was reported to be significantly shorter in the venaseal group as compared with the closurefast group (43 vs 104 days respectively).Two patients undergoing rfa had developed a post-procedure limb infection, both treated with antibiotics.Ulcer recurrence was reported as 19.3% overall with 22.1% in the closurefast group and 13.7% in the venaseal group.No repeated ablations were necessary because of recanalization of the target vein, and no treatment failures were identified during the study period.The author concludes that both closurefast and venaseal are safe and effective treatments to eliminate truncal venous insufficiency.Venaseal showed a superior time to wound healing compared with closurefast in both large and small ulcers.Venaseal-treated ulcers healed an average of 2.5 months more quickly than did the rfa-treated ulcers.

• 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: 13509522
• MDR Text Key: 289487174
• Report Number: 2183870-2022-00051
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• 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: 02/03/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male