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

Model Number	CF7-7-60
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
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 the heating element of the cf7-7-60 closurefast 7f 60cm catheter lost its integrity.The lumen was flushed prior to use, instructions for use were followed during preparation, procedure, and post-procedure, and a guidewire was not used for insertion.The proper temperature was reached during the procedure.The procedure was completed before the issue was identified, and no additional treatment was required.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: compression was used.Part of the coil exposed due to overheating and there was no coagulant build-up on the heating element.No error messages/codes/warnings were displayed on the rfg.There was no injury to the patient as a result of the difficulty.Image analysis one photo was received from the account.The photo appears to show a closurefast catheters heating element/ coil which appears to have some bubbling to the fep layer.While the image is consistent with the reported event no catheter identifiers are visible to establish that the connected 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.
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.No biologics were 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.No anomalies were observed along the catheter shaft.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: 22698022
• Report Number: 2183870-2025-00382
• Device Sequence Number: 15699769
• Product Code: GEI
• UDI-Device Identifier: 00763000702281
• UDI-Public: (01)00763000702281(17)261031(10)243300264(20)05
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 09/19/2025

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 Model Number: CF7-7-60
• Device Catalogue Number: CF7-7-60
• Device Lot Number: 243300264
• 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: 07/12/2025
• Supplement Date Received by Manufacturer: 08/20/2025; 09/16/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/03/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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