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

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	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a radiofrequency varicose vein ablation procedure using the cf7-7-60 closurefast 7f 60cm catheter, the catheter coil was burnt/melted/bubbling.The radiofrequency generator displayed a "low impedance" error when the fiber was damaged.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id radiofrequency generator (serial: unknown); product type: 0671-venous insufficiency -serial; implant date n/a; explant date n/a image analysis: two still images were returned for analysis.In the images provided the closurefast device can be seen, melting can be seen on the distal end of the closurefast catheter.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: issue occurred during the procedure during treatment of the saphenous vein.Ifu (instruction for use) was followed during preparation, procedure, post-procedure, the lumen was flushed prior to use, tumescent infiltration was utilized and compression was being applied when the issue occurred.Lidocaine anesthesia was used.It is unknown how many cycles were delivered.Another closurefast catheter was used to complete the procedure.No additional treatment was required and no patient symptoms or complications associated with this event.The vein closed.The radiofrequency generator (serial: (b)(6)) has been used successfully since the event.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: 21917022
• Report Number: 2183870-2025-00214
• Device Sequence Number: 9031725
• Product Code: GEI
• UDI-Device Identifier: 00763000702281
• UDI-Public: 00763000702281
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• Report Date (Section B): 06/19/2025

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 Expiration Date: 08/31/2026
• Device Catalogue Number: CF7-7-60
• Device Lot Number: 242600007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/19/2025
• Date Device Manufactured: 09/16/2024
• 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