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

Catalog Number	CF7-7-100
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Detachment of Device or Device Component (2907); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A closurefast catheter was being used to treat the anterior accessory great saphenous vein (aagsv).Tumescent infiltration and local anesthesia were utilized, no compression used.  a guidewire was used for the insertion of the catheter.Proper temperature was not reached and the catheter was not responding/recognized.Error message impedance high, check connection was displayed on the rfg3.The generator was power-cycled and the error remained.The catheter was unplugged and re-connected, unit powered off and restarted.Another catheter was used with the same rfg3 to complete the procedure, four segments were treated and vein closed.The lumen was flushed prior to use, the ifu (instruction for use) was followed during preparation, procedure, post-procedure.No adjustments were made to the parameters of the generator.The impedance issue occurs consistently upon activation of the catheter.No patient complications have been reported as a result of this event.No adjustments were made to the parameters of the generator.The impedance issue occurs consistently upon activation of the catheter.When the device was returned for evaluation, it was noted that the catheter shaft was separated/fractured from the main catheter body.
Additional Manufacturer Narrative
Product analysis no damage was noted to the catheter heating element/coil.The catheter reference key shows evidence of wear, and the red ink was visible in some areas.All pins were visually inspected to be straight.The catheter shaft was fractured/detached from the main catheter body at approx.98cm.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CLOSUREFAST CATHETER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): Covidien; boulevard insurgentes 19030; tijuana,mx
• Manufacturer (Section G): Covidien; boulevard insurgentes 19030; tijuana,mx
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50449793
• Report Number: 9610849-2026-00173
• Device Sequence Number: 15893397
• Product Code: GEI
• UDI-Device Identifier: 00763000702274
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K111887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 260260195
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female