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

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

Patient Problems Burn(s) (1757); Ecchymosis (1818); Pain (1994); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Endovenous ablation of varicose veins - current status and overview of methods rozhledy v chirurgii 2022, roc.101, c.5 rozhl chir.2022;101:200¿210.Doi:10.33699/pis.2022.101.5.200¿210.Date of event: date of publication - year valid.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.

Event Description

During the last two decades, superficial venous surgery has experienced an unprecedented boom.Traditional surgical procedures (crossectomy and stripping) are now being replaced to a greater or lesser extent by new less invasive endovenous methods.Our aim is to provide an up-to date review of all available endovenous techniques (laser, radiofrequency, steam, mechanochemical ablation and venous glue) describing the indications, the technique and mechanism of action, and the results.In experienced hands, all endovenous techniques are safe and effective, with long-term results comparable to conventional surgical procedures.Closurefast outpatient execution of most endovenous procedures and early, respectively immediate mobilization significantly reduces the risk of possible thromboembolic complications.3.6.Efficacy, safety and possible side effects endovenous thermal methods excellent clinical results are known after 4 to 5 years and a long-term effect is documented after 10 even more years.Several studies have presented moderate results occlusion above 94% for all endovenous thermal ablation [9,10,26,27].When comparing disease returns (clinical recurrence and reflux recurrence) with classic surgical intervention (high ligation and stripping) does not indicate most studies found a significant difference [7].Overall efficiency and lower morbidity lead to increasing popularity and the increasing number of endovenous procedures vs classic operations.Endovenous thermal methods are much less invasive and have a lower complication rate than classic operations.The procedures are safe, well tolerated by patients and have good cosmetic results.Side effects are rare and include thrombophlebitis (7%), hyperpigmentation (5%), paresthesia (4-8%), ecchymoses (0-7%), postoperative pain and thermal damage skin [8].Serious complications are rarely observed.The reported incidence of dvt in endovenous of thermal performance varies between 0.2% and 1.3%.Thermal intravenous methods are significantly associated with vsp higher incidence of nerve damage compared to vsm.This is due to the proximity of the sural nerve and the vsp in the distal parts of the calf [28].Therefore, collateral is recommended venous access at most in the middle of the calf and groin for vsm, it is recommended to ensure the entrance to the vein more distally than 10-15 cm below the knee.Thrombus development in the saphenofemoral junction area (ehit, endovenous heat induced thrombosis) is reported in a limited number of cases with a frequency between 0.3% to 7.8% of patients after endovenous thermal performances.If the thrombus extends into the vfc, it recommends with anticoagulant treatment.Pulmonary embolism has been reported in 0% to 3% [7].Routine use of pharmacological prophylaxis however, it remains uncertain and further clinical trials are needed studies.

• 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: 14998094
• MDR Text Key: 295770388
• Report Number: 2183870-2022-00233
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• 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: 07/01/2022
• 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