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

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

Patient Problems Nerve Damage (1979); Phlebitis (2004); Thrombosis/Thrombus (4440)

Event Date 04/24/2021

Event Type  Injury  

Event Description

A journal article was submitted detailing a study to compare the use of high saphenous ligation and stripping, radiofrequency ablation, and subfascial endoscopic perforator surgery for the treatment of active venous ulcers.195 patients were included in the study.The patients were split into 3 groups.Patients in group b (n=65) were treated with medtronic¿s closurefast catheter.Saphenous nerve injury (sni) is reported in 11 patients, which were treated with vitamin b12.After six months of follow-up, all snis had returned to normal function.Phlebitis is reported in 2 patient¿s.Subjects with phlebitis were very limited only around the phlebectomy and treated with amoxicillin¿clavulanic acid 1 gr, b.I.D., low molecular weight heparin (lmwh), and paracetamol.All subjects¿ phlebitis was treated with one-week follow-up.Deep vein thrombosis (dvt) is reported in one case with thrombus in the common femoral vein on duplex ultrasound evaluation at the first follow-up visit.Patient was treated with lmwg and warfarin.Between three to six months, complete recanalization was achieved at duplex controls.At 5-year follow-up recovery rate for group b was reported as 89.2%.

Manufacturer Narrative

Title: comparison of high saphenous ligation and stripping, radiofrequency ablation, and subfascial endoscopic perforator surgery fo r the treatment of active venous ulcers: retrospective cohort with five-year author: yusuf kuserli, ali aycan kavala, saygin turkyilmaz journal: vascular year: 2021 vol/issue: 30(2) ref: 10.1177/17085381211011356.Age or date of birth: average age.Gender: majority gender.Date of event: date of publication medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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: 14447160
• MDR Text Key: 293447038
• Report Number: 2183870-2022-00180
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• 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: 05/04/2022
• 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: 57 YR
• Patient Sex: Male