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

Model Number	CF6-8-100
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that a physician was performing superficial vein treatment using a closurefast catheter and the heating went up above the typical threshold and the error message "disconnect catheter" was displayed on the generator.The device was prepped as per the ifu.Compression was used within normal limits.No damage was noted to the coil.No coagulant build up on the heating element.A replacement closurefast catheter was used without issue to complete the procedure.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information the device was in the patient when the issue occurred but no harm occurred to the patient.The error message "the connected device is broken.Please connect another device" was displayed on the rfg screen.Product analysis.The image appears to show the generator screen of a rfg3 generator with an error message ¿the connected device is broken.Please connect another device¿.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.
Event or Problem Description
It was reported that a physician was performing superficial vein treatment using a closurefast catheter and the heating went up above the typical threshold and the error message "disconnect catheter" was displayed on the generator.The device was prepped as per the ifu.Compression was used within normal limits.No damage was noted to the coil.No coagulant build up on the heating element.A replacement closurefast catheter was used without issue to complete the procedure.No patient complications have been reported as a result of this event.Additional information 2026-jan-01: the device was in the patient when the issue occurred but no harm occured to the patient.The error message "the connected device is broken.Please connect another device" was displayed on the rfg screen.

• Brand Name: CLOSUREFAST 6FR CATHETER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN; boulevard insurgentes 19030; tijuana,mx 22226 ; MX 22226
• Manufacturer (Section G): COVIDIEN; boulevard insurgentes 19030; tijuana,mx 22226 ; MX 22226
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23863868
• Report Number: 9610849-2025-00120
• Device Sequence Number: 9963509
• Product Code: GEI
• UDI-Device Identifier: 00763000552176
• UDI-Public: (01)00763000552176(17)270531(10)251670199(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 01/14/2026

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 Model Number: CF6-8-100
• Device Catalogue Number: CF6-8-100
• Device Lot Number: 251670199
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 01/01/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 06/16/2025
• 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