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

Catalog Number	CF6-8-60
Medical Device Problem Codes	Overheating of Device (1437); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient with lower extremity venous insufficiency underwent a procedure to treat the great saphenous vein using the closurefast catheter.During the procedure, the catheter connection area melted, bent, and became adhered, resulting in catheter connection and pin damage, as well as bent pins.There was difficulty connecting or removing the catheter connector, and excessive force was required to remove the catheter from the generator.The vein did not close.The procedure was completed by replacing the catheter with a new one, and two treatment segments were addressed.Tumescent infiltration and local anesthesia were utilized, and hand compression was applied.The instructions for use were followed, the lumen was flushed prior to use, and the proper temperature was reached.No error codes or warnings were reported from the generator, and all pins remained on the connector.The patient remained alive with no injury.No patient complications have been reported as a result of this event.Additional information 2026-jan-21: the red mark was aligned when the connector was inserted into the generator.Compression was not being applied when the issue occurred and no adjustments were made to the parameters of the generator.The first damaged catheter was safely removed from the patient, though there was some pulling sensation during the process.There was no vessel damage.The second catheter was used with the same rfg and was successful (the vein closed).
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.
Additional Manufacturer Narrative
Image analysis one still image was provided for evaluation.1st image: the image appears to be a kinked and burnt closurefast catheter heating element/ coil.While the image is consistent with the reported event, no catheter identifiers are visible to establish that the pictured device is related to the complaint on file in gch (lot#, size or device label/ shelf carton).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 6FR 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: 24160997
• Report Number: 9610849-2026-00014
• Device Sequence Number: 21114551
• Product Code: GEI
• UDI-Device Identifier: 00763000552169
• UDI-Public: (01)00763000552169(17)270131(10)250550053(20)01
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2026

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: 250550053
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/21/2026
• Date Device Manufactured: 02/24/2025
• 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 Age: 69 YR
• Patient Sex: Female