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

Catalog Number	CF7-7-60
Medical Device Problem Codes	Overheating of Device (1437); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure involving the cf7-7-60 closurefast 7f 60 cm catheter, a generator or display issue occurred.Specifically, the generator powered on but the screen did not come on, and the generator later stopped with the display showing low impedance.The catheter could not be used.The lumen was flushed prior to use, a guidewire was used for insertion, and proper temperature was reached.When the operator pressed ablation button of the rfa catheter, catheter's temperature was high not 120 degree.The operator continued with the procedure despite the display issue, but ultimately used another catheter to complete the procedure.No additional treatment was required.No patient complications have been reported as a result of this event.When the device was returned for evaluation it was noted that the coil was damaged.
Additional Manufacturer Narrative
Product analysis: device was decontaminated with cidex opa solution soak and tergazyme soak.No ancillary devices or images were returned with the device.Heating element/coil deformed/kinked.Burnt biologics observed.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.4.8cm 50.9cm from the distal tip of the device.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 = 84.0 ohms test 2.(tc+/ tc- test) (specification: = 250 ohms) ¿ result = 111.8 ohms test 3.(resistor 1) (specification: 13.43 to 13.97 k ohms) result = 13.66 k ohms) test 4.(resistor 2) (specification: 7.90 k ohms to 8.22 k ohms) result = 0 k ohms test 4 (resistor 2) failed.Test 1, test 2, and test 3 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 low.Replace device.¿ being seen on both the rfg2 and rfg3 generators.Additional photo for pins check taken after testing and connection to generators shows pins to be straight.The device failed continuity/resistance and functional testing.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 & ACCES
• Manufacturer (Section D): COVIDIEN; boulevard insurgentes 19030; tijuana,mx ; MX
• Manufacturer (Section G): COVIDIEN; boulevard insurgentes 19030; tijuana,mx ; MX
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23989557
• Report Number: 9610849-2026-00003
• Device Sequence Number: 21378591
• Product Code: GEI
• UDI-Device Identifier: 00763000702281
• UDI-Public: (01)00763000702281(17)261130(10)243510234(20)05
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2026

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: CF7-7-60
• Device Lot Number: 243510234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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