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

Catalog Number	CF7-7-100
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Overheating of Device (1437); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
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 during a procedure to treat chronic venous insufficiency in the great saphenous vein using the closurefast radiofrequency (rf) catheter, resistance was felt during catheter removal and the generator indicated a device malfunction.It is not known what error message was displayed on the rfg.The heating part of the catheter was damaged when force was applied to remove it.The coil was exposed.The catheter was replaced to complete the procedure.Tumescent infiltration and local anesthesia were utilized, and hand compression was used.The vein closed successfully and the procedure was completed using a new catheter.No patient symptoms or complications were associated with this event.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Image analysis:four still images were provided for evaluation.1st image 2nd image: both images appear to show a detached/ unraveled and overheated heating element/ coil of a closurefast catheter.3rd image: the image is of the box label.The model number on the label was cf7-7-100 which is consistent with what was reported.4th image: the image is of a box label.The lot number on the label appears to be 242180256 which is consistent with what was reported.Product analysis the distal tip of the catheter was deformed.Examination revealed dried biologics at the distal tip of the catheter body where the heating element/coil detached.The heating element was detached from the catheter body, and damage was noted along the heating coil/element.Heating element detached from the main catheter body at approx.5 cm 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 two kinks along the shaft, the kinks were observed at approx.38.7cm, 70.1 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 & 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: 24094144
• Report Number: 9610849-2026-00007
• Device Sequence Number: 10468698
• Product Code: GEI
• UDI-Device Identifier: 00763000702274
• UDI-Public: (01)00763000702274(17)260731(10)242180256(20)05
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 03/04/2026

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 Expiration Date: 07/31/2026
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 242180256
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2024
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 80 KG