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

Catalog Number	CF7-7-100
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
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 during use of the cf7-7-100 closurefast 7f 100cm catheter, the coil burned and high temperature was observed.This issue was noted for 4 catheters.A replacement catheter was used to complete the procedure.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: the four catheters were used in 4 different patients.Compression was utilized.The coil issue was discovered post use in the patient and there was coagulant build-up on the heating element.There was no damage noted to coil and the coil was not exposed.It is unknown if any error messages/codes/warnings were displayed on the rfg.The catheters were safely removed from the patient and no vessel damage was noted.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
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 no damage was noted to the catheter 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 noted along the catheter shaft.The catheter connector was plugged into the resistance tester to perform continuity/resistance and connected to rfg for functional testing; the catheter was tested according to the test parameters, test methods, and acceptance criteria.Test 1.(e+/ e- test) (specification: 80 ohms to 113 ohms) ¿ result = 0l ohms - fail test 2.(tc+/ tc- test) (specification: = 250 ohms) ¿ result = 158.5 ohms test 3.(resistor 1) (specification: 13.43 to 13.97 k ohms) result = 13.68 k ohms) test 4.(resistor 2) (specification: 7.90 k ohms to 8.22 k ohms) result = 8.06 k ohms) test 1 (e+/ e- test) failed.Tests 2, test 3, and test 4 passed and are inside the specification and acceptance criterion.The catheter was connected to both the rfg3 and rfg2 lab generator, the device did not complete the required cycle with an error message ¿advisory: impedance high.Check connection.¿ being seen on both the rfg2 and rfg3 generators addition photo for pins check taken after testing and connection to generators shows pins to be straight 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
Additional information: all issues occurred on the same date.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; 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: 23276748
• Report Number: 9610849-2025-00071
• Device Sequence Number: 5519758
• Product Code: GEI
• UDI-Device Identifier: 00763000702274
• UDI-Public: (01)00763000702274(17)260831(10)242460009(20)05
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup,Followup
• Report Date (Section B): 01/12/2026

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 Expiration Date: 08/31/2026
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 242460009
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 10/22/2025; 11/07/2025; 11/17/2025; 12/23/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/06/2025; 11/17/2025; 11/27/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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