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

Catalog Number	CF7-7-60
Medical Device Problem Codes	Overheating of Device (1437); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No ancillary devices were returned with the device.Damage was noted along the heating coil/element microscopic examination revealed peeling and burnt biologics along the heating coil.The coil was not exposed 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 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 = 86.3 ohms test 2.(tc+/ tc- test) (specification: = 250 ohms) ¿ result = 113.6 ohms test 3.(resistor 1) (specification: 13.43 to 13.97 k ohms) result = 13.71 k m ohms test 4.(resistor 2) (specification: 7.90 k ohms to 8.22 k ohms result = 8.06 k ohms all 4 tests passed as per the acceptance criteria.The catheter was connected and recognized by both the rfg3 and rfg2 lab generators when plugged in.When the temperature rose to 120 c, the device completed the cycle without seeing an advisory message 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 a physician placed the long catheter just before the cross without any problems, then administered the tumescent solution and began radiofrequency therapy.The first cycles started, then a message appeared on the generator: ¿low temperature, adjust compression.¿ despite adjusting the catheter slightly downwards and without compression, it wouldn¿t go any further.Physician tried starting the cycles several times, but they kept stopping after 2¿3 seconds with the message: ¿temperature cannot be reached, termination¿.Even changing the generator or placing the catheter deeper made no difference; therapy was impossible.Physician then inserted a new rf catheter, which worked absolutely fine.However, catheter could no longer push all the way to the groin, but only about 10 cm or deeper below the groin.The first catheter must have had some effect here, as it also looked very strange.No allegation against the rfg.When the device was returned it was noted that the coil was damaged.

• Brand Name: CLOSUREFAST CATHETER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• 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: 25256359
• Report Number: 9610849-2026-00115
• Device Sequence Number: 5431894
• Product Code: GEI
• UDI-Device Identifier: 00763000702281
• UDI-Public: (01)00763000702281(17)270731(10)252300304(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
• Report Date (Section B): 05/22/2026

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: 252300304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 08/18/2025
• 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