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	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted to use a closure fast ablation device for patient treatment in the great saphenous vein (gsv).Local anesthesia was used.Ifu was followed.Model and serial number of generator of generator used was rfg2.It was reported that the catheter terminal was burnt.The device was replaced and used successfully.No patient injury was reported for 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.
Event or Problem Description
Physician attempted to use a closure fast ablation device for patient treatment in the great saphenous vein (gsv).Local anesthesia was used.Ifu was followed.Model and serial number of generator of generator used was rfg2/20152017ars.It was reported that the catheter terminal was burnt.The device was replaced and used successfully.No patient injury was reported for this event.
Additional Manufacturer Narrative
Product analysis #819832579:707435081-10 analysis: reported event: physician attempted to use a closure fast ablation device for patient treatment in the great saphenous vein (gsv).Local anesthesia was used.Ifu was followed.Model and serial number of generator of generator used was rfg2/20152017ars.It was reported that the catheter terminal was burnt.The device was replaced and used successfully.No patient injury was reported for this event.Returned device: device received in a biohazard bag.Lot no.On the device matches that on gch.Lot # 240220213 was additionally confirmed on the device catheter label (photo 1-2).Label detached.No ancillary devices or images were returned for analysis.Heating element/coil condition: damage was noted along the heating coil/element (photo 3).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 (photos 4-7).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 (photo 8).All pins were visually inspected to be straight (photo 9).No other anomalies were observed along the catheter shaft.Analysis result: the reported event ¿that the catheter terminal was burnt¿ could be confirmed.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.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: 21262472
• Report Number: 2183870-2025-00041
• Device Sequence Number: 9412508
• Product Code: GEI
• UDI-Device Identifier: 00643169862968
• UDI-Public: 00643169862968
• 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
• Report Date (Section B): 04/02/2025

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: 12/31/2025
• Device Model Number: CF7-7-60
• Device Catalogue Number: CF7-7-60
• Device Lot Number: 240220213
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 67 KG