MAUDE Adverse Event Report: COVIDIEN RADIOFREQUENCY GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problems Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Phlebitis (2004); Skin Discoloration (2074); Numbness (2415); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

Journal article title: outcome of closurefast radiofrequency ablation for large-diameter incompetent great saphenous vein - annals of surgical treatment and research original article: pissn 2288-6575 ¿ eissn 2288-6796 https://doi.Org/10.4174/astr.2019.96.6.313 annals of surgical treatment and research.Patient age: average age.Sex: majority gender.Event date: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a retrospective single-centre study including patients who underwent rfa due to symptomatic varicose vein with saphenofemoral junction (sfj) reflux.493 patients¿ (722 limbs) were treated.The patients were split into 2 groups (group a 663 veins) and group b (59 veins) dependent on vein diameter which was measured 3cm below the sfj.Medtronic¿s closurefast catheter and rfg were used during the procedures.Concomitant ambulatory phlebectomy was performed in 605 patients (91.3%) in group a and 59 patients (100%) in group b.Follow-up ultrasound evaluation was performed between 3 to 5 days, and at 1, 3, 6, and 12 months postoperatively.Successful closure of the treated gsv was achieved in all patients, and was evaluated with a duplex scan at the end of the procedure.Vein closure rates evaluated with duplex scan in group a were 100%, 99.7%, and 98.9% at 1 month, 6 months, and 12 months, respectively.Postoperative complications were found in 132 patients (19.9%) in group a and 8 patients (13.6%) in group b.Complications of hematoma, edema, induration, paresthesia, hyperpigmentation, phlebitis, ehit were reported.Paresthesia disappeared in most cases without additional treatments.Most patients with phlebitis only required the medications for a few days without the need for hospitalization.Two patient¿s experienced class 3 ehit and required anticoagulation therapy.The ehit is reported to have resolved.

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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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: RADIOFREQUENCY GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10918288
• MDR Text Key: 218688280
• Report Number: 2183870-2020-00402
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K141858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR