MAUDE Adverse Event Report: COVIDIEN CLOSUREFAST 6FR CATHETER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Catalog Number CF6-8-100

Device Problems Overheating of Device (1437); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A closurefast rfa catheter was  used with an rfg3 for treatment of the great saphenous vein (gsv) and short saphenous vein (ssv).The lumen was flushed prior to used.The ifu was followed.The appropriate temperature was reached.It was reported at the end of the procedure , when finishing the last vein segment the catheter kinked and once it was removed from the patient the heating element was also noted to be damaged with the coil exposed.No error messages/codes/warnings displayed on the rfg.The vein closed and no additional treatment was required.

Manufacturer Narrative

Images analysis: film image 1: "image received of a seemingly damaged heating element/coil of a closurefast catheter.Heating element/coil of device appears to have burnt biologics/bubbling of the fep layer of the heating element/coil, consistent with the reported event lot number of the device could not be confirmed based on the returned image." image 2: "image received of a seemingly kinked closurefast catheter, consistent with the reported event.Lot number of the device could not be confirmed based on the returned image." product analysis: returned device: lot #230300270 confirmed on the device catheter label.An introducer was returned with the device.The catheter cable connector was examined: all pins were visually inspected to be straight, and no anomalies were noted along the catheter shaft.The catheter reference key shows evidence of wear, and the red ink was visible in some areas.Heating element/coil condition: damage was noted along the heating coil/element.Microscopic examination revealed burnt biologics/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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLOSUREFAST 6FR CATHETER
• Type of Device: 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: 18301748
• MDR Text Key: 330174554
• Report Number: 2183870-2023-00430
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00763000552176
• UDI-Public: 00763000552176
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K223488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CF6-8-100
• Device Lot Number: 230300270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2024
• Date Device Manufactured: 03/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male