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

Catalog Number	CF7-7-60
Medical Device Problem Codes	Overheating of Device (1437); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a closurefast catheter was being used to treat the great saphenous vein (gsv).Tumescent infiltration, local anesthesia and hand compression were utilized.  a guidewire was used for the insertion of the catheter.The proper temperature was reached.During the procedure the catheter became kinked on the coil.The catheter was replaced with a new one, and the procedure completed, two segments were treated and the vein closed. the lumen was flushed prior to use and the ifu (instruction for use) was followed during preparation, procedure, post-procedure. no patient complications have been reported as a result of this event.When the device was returned for evaluation, it was noted that the catheter was damaged.
Additional Manufacturer Narrative
Product analysis: damage was noted to the catheter heating element/coil.Examination revealed bubbling/bending/kinking of the heating element/coil.The heating element/coil was not exposed; white residue was observed beneath the fep layer and on the element coils.The bubbling/burning/bending/kinking was observed at approx.1.0 cm, 7.0 cm from the distal tip of the device.The catheter cable connector was examined: 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.Visual inspection of the returned catheter revealed three kinks along the shaft; the kinks were observed at approx.14.2 cm, 42.9 cm, 49.1 cm from the distal tip of the 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.

• 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: 50684888
• Report Number: 9610849-2026-00176
• Device Sequence Number: 5315788
• Product Code: GEI
• UDI-Device Identifier: 00763000702281
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CF7-7-60
• Device Lot Number: 260750337
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2026
• 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: 73 YR
• Patient Sex: Female