MAUDE Adverse Event Report: COVIDIEN CLOSUREFAST 6FR CATHETER; INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE

Catalog Number	CF6-8-100
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Overheating of Device (1437); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the closurefast catheter was not responding and was not recognized by the radiofrequency generator during a procedure for venous insufficiency.The generator displayed the message: "the connected device is unsupported.Please connect another device." there was damage to the catheter plug, it was just not recognized by the radiofrequency generator.The red mark was aligned when the connector was inserted into the generator.No bent pins, all pins remained on the catheter connector and the rfg socket was inspected.The software version on the generator was radio frequency generator 3 version 1.14.2.No patient complications have been reported as a result of this event.When the device was returned for evaluation, it was noted that the probe was damaged.
Additional Manufacturer Narrative
Product analysis damage was noted along the heating coil/element.Microscopic examination revealed peeling/ bubbling of the fep layer of the heating element/coil.Examination also revealed the heating element/coil of the device was exposed device did not undergo functional and continuity/resistance testing due to the damage seen to 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 three kinks along the shaft, the kinks were observed at approx.33.9 cm, 42.1 cm45.0 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 6FR CATHETER
• Common Device Name: INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE
• 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: 24696960
• Report Number: 9610849-2026-00078
• Device Sequence Number: 21442454
• Product Code: FEI
• UDI-Device Identifier: 00763000552176
• UDI-Public: (01)00763000552176(17)270131(10)250550276(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 03/26/2026

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: CF6-8-100
• Device Lot Number: 250550276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Female