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	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis no ancillary devices or images were returned with the device.Damage was noted to the catheter heating element/coil.Examination revealed bubbling/ burning/ bending of the heating element/coil.The bubbling/ burning/ bending was observed between approx.4.0 - 4.5 cm from the distal tip of the device.The heating element/coil was not exposed 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 the catheter connector was plugged into the resistance tester to perform continuity/resistance and connected to rfg for functional testing; the catheter was tested according to the test parameters, test methods, and acceptance criteria.Visual inspection of the returned catheter revealed three kinks along the shaft; the kinks were observed at approx.18.7 cm, 22.7 cm <(><<)>(> <(>&<)><(><<)>)> 51.7 cm from the distal tip of the device test 1.(e+/ e- test) (specification: 80 ohms to 113 ohms) ¿ result = 86.8 ohms test 2.(tc+/ tc- test) (specification: = 250 ohms) ¿ result = 112.5 ohms test 3.(resistor 1) (specification: 13.43 to 13.97 k ohms) result = 13.67 k ohms) test 4.(resistor 2) (specification: 7.90 k ohms to 8.22 k ohms) result = 8.06 k ohms) all 4 tests are within specification and passed as per the acceptance criteria.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 7f 60 cm catheter was used during an endovenous procedure to treat venous insufficiency of the great saphenous vein, with the full length treated and the vein reported as closed.Tumescent infiltration was utilized with local anesthesia, and hand compression was used.Proper temperature was reached.Post-procedure, the heating element was reported to be bent.The procedure was reported as completed per the instructions for use.No patient complications have been reported as a result of this event.When the device was returned for evaluation, it was noted that th coil was damaged.
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.

• Brand Name: CLOSUREFAST CATHETER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 25200957
• Report Number: 9610849-2026-00106
• Device Sequence Number: 10009993
• Product Code: GEI
• UDI-Device Identifier: 00763000702281
• UDI-Public: (01)00763000702281(17)271031(10)253140191(20)05
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/07/2026

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: 253140191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 06/07/2026
• Date Device Manufactured: 11/10/2025
• 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