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

Catalog Number	CF7-7-100
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure to treat venous insufficiency in the great saphenous vein using a cf7-7-100 closurefast 7f 100cm catheter, the coil unraveled and an error code indicated that the temperature was not reached due to compression not being uniform.No part of the coil was exposed and no coagulant build-up on the heating element.Tumescent infiltration and local anesthesia were utilized, and hand compression was applied.Three segments of the vein were treated, and the vein successfully closed.No vessel damage was noted.The procedure was completed using a new catheter, and no additional treatment was required.No patient complications have been reported as a result of this event.When the device was received for evaluation it was noted that the coil was exposed.
Additional Manufacturer Narrative
Product analysis heating element/coil condition: damage was noted along the heating coil/element.Microscopic examination revealed bubbling/ peeling/ burning of the fep layer of the heating element/coil.No coagulants or biologics were observed.Examination also revealed the heating element/coil of the device was exposed.Device did not undergo functional and continuity/resistance testing due to the damage seen to the 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 visual inspection of the returned catheter revealed one kink along the shaft, the kink was observed at approx.41.3 cm from the distal tip of the device 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; 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: 21443914
• Report Number: 2183870-2025-00098
• Device Sequence Number: 7320151
• Product Code: GEI
• UDI-Device Identifier: 00763000702274
• UDI-Public: 00763000702274
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/24/2025

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: 05/31/2026
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 241760122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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