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

Catalog Number	CF6-8-60
Medical Device Problem Codes	Entrapment of Device (1212); Overheating of Device (1437); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis one still image was provided for evaluation.1st image: the image appears to be a closurefast catheter heating element/ coil.There appears to be burning and biologics visible on the mid section of the coil.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 after treating the first segment of the great saphenous vein in the right and left proximal peripheral veins with two cycles using the closurefast catheter, pullback was experienced for the remainder of the procedure.A second catheter was used.Upon removal of the catheter from the patient, a visible charred vein and coagulation on the heating element were observed, along with coil damage characterized by burnt residue and coagulant build-up on the heating element.The lumen was flushed prior to use, tumescent infiltration and general anesthesia were utilized, and compression with a transducer was applied.No resistance was encountered when advancing the device, and the instructions for use were followed without issue.No error messages were displayed on the generator, and the devices was safely removed from the patient.The procedure was completed successfully using a new device and the vein was closed.No injury/intervention associated with this event.No health consequences or impact were reported for the patient.No patient complications have been reported as a result of this event.Difficulty in removing the catheter was confirmed for the first catheter and the coil was exposed on the second catheter with coagulation on the heating element, as well as vein fragment.The physician reported that the patient did not sustain injury.

• 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 ; 091708096
• MDR Report Key: 24673490
• Report Number: 9610849-2026-00075
• Device Sequence Number: 21386157
• Product Code: GEI
• UDI-Device Identifier: 00763000552169
• UDI-Public: (01)00763000552169(17)271130(10)253350241(20)01
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: 253350241
• 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: 02/25/2026
• Initial Report FDA Received Date: 03/24/2026
• Date Device Manufactured: 12/01/2025
• 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: Female