MAUDE Adverse Event Report: COVIDIEN CLOSUREFAST CATHETER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

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	05/20/2026
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 closurefast catheter was used to treat venous insufficiency of the great saphenous vein under general anesthesia with tumescent infiltration and hand compression. the catheter was flushed prior to use, proper temperature was reached, and the instructions for use were followed. after three cycles, bubbling was noted to the fep liner, with burnt residue and a kink also observed.The bare coil was not exposed. another device was used to complete the procedure and vein closure was achieved.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis damage was noted along the heating coil/element.Microscopic examination revealed peeling/ kinking/ burning of the fep layer of the heating element/coil 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 one kink along the heating element/coil, the kink was observed at 3.2cm from the distal tip of the device image analysis: one still image was provided for evaluation.Burned biological material appears to be present on the coils.The distal section of the catheter also appears to be bent or kinked.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 & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; boulevard insurgentes 19030; tijuana,mx ; MX
• Manufacturer (Section G): COVIDIEN; boulevard insurgentes 19030; tijuana,mx ; MX
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 25253335
• Report Number: 9610849-2026-00114
• Device Sequence Number: 5419602
• Product Code: GEI
• UDI-Device Identifier: 00763000702281
• UDI-Public: (01)00763000702281(17)271231(10)260330027(20)05
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/18/2026

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: CF7-7-60
• Device Lot Number: 260330027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Supplement Date Received by Manufacturer: 05/23/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 06/18/2026
• 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 Sex: Unknown