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	09/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient was treated for lower extremity venous insufficiency using the closurefast 7f 60cm catheter during a procedure on the great saphenous vein, with two segments treated under local anesthesia and tumescent infiltration.An abnormality was observed on the heating element surface of the catheter after two treatment cycles, specifically at 1 cm from the tail, where it was suspected that blood had burned and adhered to the heating element.The adhesion was removed by gently using a scalpel.The procedure was completed by replacing the affected catheter with another catheter.No patient complications have been reported as a result of this event.
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
Additional information: during the device malfunction, the rfg3 generator displayed no errors or alarms.The device had already been removed from the patient before using the scalpel to dissect the adhesions.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 (photo 4).All pins were visually inspected to be straight visual inspection of the returned catheter revealed one kink along the shaft; the kink was observed at approx.48.9 cm (ruler cal: 803523) 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 = 85.4 ohms test 2.(tc+/ tc- test) (specification: = 250 ohms) ¿ result = 112.0 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 = 8.05 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 (photo 11-12).Image analysis one image was received from the account.The image appears to show the heating element / coil of a closurefast device which has overheated/ become exposed.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: 23277588
• Report Number: 9610849-2025-00073
• Device Sequence Number: 21021420
• Product Code: GEI
• UDI-Device Identifier: 00763000702281
• UDI-Public: (01)00763000702281(17)261031(10)243160309(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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2025

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: 243160309
• 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: 09/28/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 12/04/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/11/2025; 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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 Age: 41 YR
• Patient Sex: Female