MAUDE Adverse Event Report: Covidien CLOSUREFAST 6FR CATHETER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Catalog Number	CF6-8-60
Medical Device Problem Codes	Overheating of Device (1437); Difficult to Remove (1528); Material Deformation (2976); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a closurefast catheter was used for radiofrequency ablation of the great saphenous vein for venous insufficiency, during which four vein segments were treated with tumescent infiltration, local anesthesia, and hand compression.During the first segmental ablation, the radiofrequency machine displayed a ¿target temperature cannot reach¿ alert and stopped the procedure.The physician restarted the radiofrequency cycle, the alert did not recur, and the procedure was completed.During catheter removal, the catheter became stuck at the puncture site and was safely removed.Kinking and damage were observed on the catheter ablation segment.The vein closed successfully, and no additional treatment was required.No patient complications have been reported as a result of this event.No intervention was required to remove the device.The procedure was stopped once messaged said ¿target temperature cannot reach¿ popped out.After that, the procedure was completed as usual.
Additional Manufacturer Narrative
Image analysis: two still images were provided for evaluation.1st image: the image appears to be a closurefast heating element with evidence of bubbling/ overheating.2nd image: again, the image appears to be a closurefast heating element with evidence of bubbling/ overheating.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 6FR 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: 50814620
• Report Number: 9610849-2026-00182
• Device Sequence Number: 10648429
• Product Code: GEI
• UDI-Device Identifier: 00763000552169
• UDI-Public: (01)00763000552169(17)271231(10)260120214(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: CF6-8-60
• Device Lot Number: 260120214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 01/12/2026
• 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 Sex: Unknown