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

Catalog Number CF7-7-100

Device Problems Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Output Problem (3005)

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

Event Date 02/18/2024

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 catheter was being used for treatment of the great saphenous vein (gsv).The ifu was flushed.The ifu was followed.Tu mescent fluid and compression were used.It was reported the temperature of the device would not rise to 120 degrees, , it has been tried repeatedly up to 22 rf cycles but it remains the same.In 1 segment that had been burned, the doctor evaluated it using ultrasound, the gsv in that segment was not closed.Treatment was carried out repeatedly with the addition of tumescent and compression but the temperature did not reach 120 degrees so it was replaced with a new closurefast catheter with batch/lot: 231210145.After being replaced, the temperature immediately rose and succeeded in burning the gsv until it closed.No patient injury was reported.

Manufacturer Narrative

Product analysis 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 seemingly exposed visual inspection of the returned catheter revealed two kinks along the shaft, the kinks was observed at approx.8.0 cm and 25.5 cm from the distal tip of the device the catheter connector was plugged into the resistance tester to perform continuity/resistance and connected to rfg for functional testing; the catheter was tested according to the test parameters, test methods, and acceptance criteria test 1.(e+/ e- test) (specification: 80 ohms to 113 ohms) ¿ result = 87.8 ohms test 2.(tc+/ tc- test) (specification: = 250 ohms) ¿ result = 160.1 ohms test 3.(resistor 1) (specification: 13.43 to 13.97 k ohms) result = 13.79 k ohms) test 4.(resistor 2) (specification: 7.90 k ohms to 8.22 k ohms) result = 8.12 k ohms) all 4 tests passed as per the acceptance criteria.The catheter was connected and recognized by both the rfg3 and rfg2 lab generators when plugged in.When the temperature rose to 120 c, the device completed the cycle without seeing an advisory message image analysis: 4 film images were returned for review film image 1: imaged received of closurefast shelf carton with a product information sheet attached to the back, not consistent with the reported event.Lot number # of the device could not be confirmed based on the returned image.Film image 2: ¿video received of surgeons using closurefast catheter during procedure, not consistent with the reported event.Lot number # of the device could not be confirmed based on the returned image.¿ film image 3: ¿video received of rfg3 generator screen during rf cycles as the generator does not seem to reach the correct temperature, consistent with the reported event.Lot number # of the device could not be confirmed based on the returned image.¿.¿ film image 4: ¿imaged received of closurefast device seemingly with burnt biologics/bubbling of the fep layer of the heating element present on th e heating element/coil, not consistent with the reported event.Lot number # of the device could not be confirmed based on the returned image.¿.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
• Type of Device: 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: 18884338
• MDR Text Key: 337417901
• Report Number: 2183870-2024-00081
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00643169862982
• UDI-Public: 00643169862982
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K111887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 231210145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female