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

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

Patient Problems Phlebitis (2004); Rash (2033); Swelling/ Edema (4577)

Event Date 07/02/2021

Event Type  Injury  

Event Description

Medtronic received an article evaluating compression immediately post-venous closures and its associated costs.Patient data in the electronic medical record were retrospectively reviewed for consecutive varicose vein ablations with sclerotherapy with 3% sodium tetradecyl sulfate solution, moca and rfa performed on patients with symptomatic varicose veins from one surgical clinic with 2 cohorts.One hundred and one patients were identified who underwent venous closure procedures.The radiofrequency ablations (closurefast) were all performed percutaneously under local anesthesia with ultrasound access.Once the catheter was introduced into the target vein, it was advanced to 2 cm from the sapheno-femoral junction and tumescent (1 mg/kg 8.4% nahco3 and 25 cc lidocaine with 1/100,000 units epinephrine mixed in 250 cc normal saline) was infused circumferentially around the catheter directly under ultrasound guidance and followed to the saphenofemoral junction.The catheter tip was again checked verifying distance of 2 cm from the junction of the superficial and deep veins.The catheter was discharged sequentially in 7 cm segments directly under ultrasound guidance with gentle pressure over the ablation tract and the catheter pulled back until it was removed.All patients received unilateral venous ultrasounds within one week in the same outpatient office-based setting to check closure segments and to evaluate for deep venous thrombosis.No patients received post procedure vte prophylaxis.Postoperatively, complications including pain, wound complications such as blistering, and swelling were found in both groups.Pain was not a statistically significant difference between groups (p ¼ 0.8897) and were attributable to postoperative phlebitis.Wound complications consisted of raised area of erythema at access sites (2 rfa and 2 moca) and blistering (2 rfa with aw) and were too small to perform statistical analysis.Swelling was found more frequently in the aw group (25 cases) compared to naw group (9 cases) (p ¼ 0.0132; or 3.3951; ci 1.269¿9.0834) and were attributable to ill fitting wraps in the aw group (90%).

Manufacturer Narrative

Average age, majority gender, majority ethnicity.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: 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: 14770801
• MDR Text Key: 294497961
• Report Number: 2183870-2022-00209
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2022
• 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 Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White