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	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: heating element/coil condition: damage was noted along the heating coil/element.Microscopic examination revealed peeling/ bubbling of the fep layer of the heating element/coil.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.56.8 cm from the distal tip of the device.Image analysis: two still images were provided for evaluation.The images are of a closurefast heating element.The lot number on the label was not visible but catheter heating coil bubbling/ damage can be seen in both images provided, which is consistent with what was reported.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
Physician was attempting to use a closurefast device to treat the great saphenous vein.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.Tumescent infiltration and local anesthesia were utilized.The lumen was flushed prior to use, a guidewire was not used for the insertion of the catheter.Hand compression was utilized.Proper temperature was not reached, catheter temperature thermocouple.Catheter heating element coating damaged was reported, the coil was not exposed.The patient had gsv closure of both lower limbs, and the left leg had been completely closed.When the right leg gsv was closed, it was found that the catheter sheath could not be inserted.There were no error codes/messages/warnings from the generator.After the problem was discovered during the surgery, a new catheter was used to complete the operation.Two segments were treated, and the vein closed.No additional treatment required and no patient injury.

• 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: 21206043
• Report Number: 2183870-2025-00034
• Device Sequence Number: 3810274
• Product Code: GEI
• UDI-Device Identifier: 00763000702281
• UDI-Public: 00763000702281
• 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
• Report Date (Section B): 01/22/2025

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 Expiration Date: 05/31/2026
• Device Catalogue Number: CF7-7-60
• Device Lot Number: 241550220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 01/22/2025
• Date Device Manufactured: 06/03/2024
• 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: 69 YR
• Patient Sex: Male