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

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Scar Tissue (2060); Sepsis (2067)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Patient reported undergoing a varicose vein ablation procedure with rfg3 and closurefast device.The patient has reported negative reactions.The patient reports being burned during the procedure resulting in subsequent hospitalization for sepsis and scarring.

Manufacturer Narrative

Additional information: event date reported.Patient reported closurefast ablation was used to treat the right great saphenous vein.Patient reported being prepped with a stick/sponge on it and something happened, the stick/sponge was dropped on the floor, picked up and prepping was continued with it, but later thrown away; patient then informed physician of this.The procedure was completed and follow-up was scheduled for 2 days later.Patient left compression stockings on the entire 48 hours and when removing them during follow-up visit, patient was informed to see the physician because the treated leg did not look right.It looked like obvious burns and had blisters that formed and were about the size of a quarter.Patient was given antibiotics and percocet.Same night around 9pm, patient started vomiting and shaking, and blister were now 3 times their size.Patient was taken to er and was admitted to the hospital and spent 5 days.The blisters got so big they burst and developed into 8x13 open wound.Patient was put on 3 antibiotics via iv and the wound was weeping all over.Patient was 5 days on a medline drip.Patient then underwent home healthcare for 11days after the hospital and it has taken 1.5 months to heal the wound which is very sensitive to the touch (all new skin), painful and the skin is puckered up right there.Patient is on lyrica and taking pain medication everyday - very painful at night; elevating/icing the leg really helps.The medline drip for 5 days refers to the i.V.(intravenous) line that was used to infuse the antibiotics through to this patient.During the consultation, the physician informed that he had not ever seen anything like this before and does not know if it will go away.Patient reported that is very painful at night.  the patient elevates her leg and ices it which really helps.She is on lyrica and taking pain medications on a day basis.No further injury reported.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.

Manufacturer Narrative

Image review 12 images were provided for analysis.It is evident from the images provided that there are burn marks on the patient leg.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.

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.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 CATHETER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 11001971
• MDR Text Key: 221223794
• Report Number: 2183870-2020-00436
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K111887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention