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

Catalog Number	CF7-7-60
Medical Device Problem Codes	Overheating of Device (1437); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis bubbling damage was noted to the catheter heating element/coil.Under microscopic inspection bubbling and peeling of the heating element/ coil was observed.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 two kinks along the shaft; the kinks were observed at approx.15.8 cm 16.8 cm from the distal tip of the device image analysis:one photo was received from the complaint file.The photo shows the heating element/ coil of a closurefast device which has some evidence of bubbling.While the image is consistent with the reported event no catheter identifiers are visible to establish that the device is related to the complaint on file in gch (lot#, size or device label/ shelf carton).Conclusion: the complaint cannot be confirmed from the photo provided.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 the coating of the heating section of the cf7-7-60 closurefast 7f 60cm catheter was damaged prior to use.The issue was noted when device was removed from the packaging.The device was not used/tested in vitro.The catheter was replaced with a new one to complete the procedure.There was no patient involved.When the device was returned for analysis it was noted that the coil was exposed.

• Brand Name: CLOSUREFAST CATHETER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• 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: 23002476
• Report Number: 2183870-2025-00433
• Device Sequence Number: 15654994
• Product Code: GEI
• UDI-Device Identifier: 00763000702281
• UDI-Public: (01)00763000702281(17)260731(10)242390001(20)05
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2025

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: 07/31/2026
• Device Catalogue Number: CF7-7-60
• Device Lot Number: 242390001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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