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

Catalog Number	CF7-3-60
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	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician was attempting to use a closurefast cf7-3-60 to treat a patient.The preparation of the catheter, use of the device, and post-usage procedures was performed in accordance with the package insert and the user manual.The catheter lumen was flushed prior to use.The guidewire was used during catheter insertion and placement.The temperature at the time of heat generation increased to the set temperature.It was reported, for one lesion, two punctures were made to treat it, and after cauterizing the area near the groin, the catheter was removed from the body, whereupon it was discovered that the metal coil had become kinked.As the kinked part had also become scorched, it was decided to refrain from further use and to replace the catheter.It is unclear whether the catheter was already kinked at the time it was removed.Another catheter was opened and used to complete the procedure.No additional treatment was required.No injury to the patient as a result of the issue/scorched catheter.Compression was being applied when the issue occurred.
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 image was received from the account.The image shows the heating element/ coil of a closurefast device which appears to have a slightly scorched area and is bent at that position.While the image is consistent with the reported event no catheter identifiers are visible to establish that the device is related to this issue 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; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22289224
• Report Number: 2183870-2025-00318
• Device Sequence Number: 12984951
• Product Code: GEI
• UDI-Device Identifier: 00763000702298
• UDI-Public: (01)00763000702298(17)260228(10)240640219(20)05
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/18/2025

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: 02/28/2026
• Device Catalogue Number: CF7-3-60
• Device Lot Number: 240640219
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 08/18/2025
• Date Device Manufactured: 03/04/2024
• 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 Sex: Unknown