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

Catalog Number CF7-7-100

Device Problems Overheating of Device (1437); Activation, Positioning or Separation Problem (2906); Output Problem (3005)

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

Event Date 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation the catheter cable connector was examined: all pins were visually inspected to be straight, and no anomalies were noted along the catheter shaft.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 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 = 87.4 ohms.Test 2.(tc+/ tc- test) (specification: = 250 ohms) ¿ result = 159.0 ohms.Test 3.(resistor 1) (specification: 13.43 to 13.97 k ohms) ¿ result = 13.73 k ohms.Test 4.(resistor 2) (specification: 7.90 k ohms to 8.22 k ohms) ¿ result = 8.09 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 (photo 15-16).Image analysis 3 film images were returned for review.Image 1: ¿film received of closurefast device connected to a rfg3 generator.Generator screen is displaying an error message, consistent with the reported event.Lot number # of the device could not be confirmed based on the reported event.¿.Image 2: ¿image was received of heating element/coil of closurefast device, seemingly damaged with burnt biologics/bubbling of the fep layer apparently present on the heating element/coil, consistent with the reported event.Lot number # of the device could not be confirmed based on the returned image.".Image 3: ¿image received of previously opened medtronic closurefast pouch.".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

Physician was attempting to use a closurefast catheter during treatment of patients great saphenous vein (gsv).The lumen was flushed prior to use.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.There was no calcific or tortuous anatomy.Tumescent infiltration was utilized and spinal anesthesia was used.Hand compression was used.It is reported the catheter didn't reach proper temperature.The physician attempted several times of ablation with adequate amount of tumescent and compression.After physician evaluated it with ultrasonography (usg) the vein wasn¿t occluded and they changed the catheter with a new one to redo the procedure from the start.There were no issues with insertion or withdrawal.When catheter was withdrawn from patient burnt residue was observed on catheter, there was no coil exposed.Error message displayed on the generator ¿advisory: low tempe rature, high power, adjust compression¿.1 segment was treated and the vein is reported to have closed successfully.No additional treatment required.No patient injury reported.When the device was returned for evaluation, it was noted that the coil was exposed.

• Brand Name: CLOSUREFAST 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: 17894149
• MDR Text Key: 325298511
• Report Number: 2183870-2023-00365
• 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
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• 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: 231000304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Date Device Manufactured: 04/10/2023
• 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