MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER COOL-TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number RFA2030

Device Problems Overheating of Device (1437); Difficult or Delayed Activation (2577); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Shock (2072); Liver Failure (4492); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/25/2022

Event Type  Death  

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

According to the reporter, post-operatively, the device overheated and after twelve hours of the procedure the patient died.The patient had two nodules in the liver, one closer to the vessel.During the radiofrequency liver tumor ablation procedure, ablations of 2 tumors were performed, and one 12-minute cycle was performed in each tumor.The first ablation occurred satisfactorily without complications and approximately 4 roll offs were verified and the path was cauterized at the end.The second ablation was also performed in automatic standard mode but at 7 minutes the equipment was accused of heating the plate and stopped.When they verified that the plate was no longer heated, they waited 1 minute and resumed the standard ablation at 7 minutes and continued until 12 minutes.And at this point where they were finishing the click did not give more pulses and the power was showing higher, but managed to finish procedure.Approximately 2 roll offs were observed and cauterization was performed at the end.As an observation, they  emphasize the proximity of this ablation zone to a large vessel and the level of difficulty to access the 2nd tumor and also point out that the patient had already undergone other ablation procedures.

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.

Event Description

According to the reporter, post-operatively, the device overheated and after twelve hours of the procedure the patient came to death due to shock and liver failure.The patient had two nodules in the liver, approximately 1 cm each and one was closer to the hepatic vein.During the radiofrequency liver tumor ablation procedure, ablations of 2 tumors were performed, and one 12-minute cycle was performed in each tumor.The first ablation occurred satisfactorily without complications and approximately 4 roll offs were verified and the path was cauterized at the end.The second ablation was also performed in automatic standard mode but at 7 minutes after the cycle started the equipment to complete the plate, they stopped, checked if the plate was hot but it was not.When they verified that the plate (that was adhered to the patient) was no longer heated, they waited 1 minute and resumed the standard ablation at 7 minutes and continued until 12 minutes.And at this point where they were finishing, the click did not give more pulses and the power was showing higher, but managed to finish procedure.Approximately 2 roll offs were observed and cauterization was performed at the end.When they say rolling off, they meant that the energy delivered to the tumor was "interrupted", so that there was no carbonization of the tissue.As an observation, they  emphasize the proximity of this ablation zone to a large vessel and the level of difficulty to access the 2nd tumor and also point out that the patient had already undergone other ablation procedures.After the ablation, the patient went to recovery and presented severe shock and went straight to icu (intensive care unit).Due to this, an ultrasound was performed.The generator was on default setting, initially the power was in minute at 50 in the first then to 100 in the second minute and full in the rest.It also displayed an alert "board return message" so they checked the ice, the connections, and the board.There was only one grounding plate used on this event.Imaging tests were used such as mri (magnetic resonance imaging) or ct ( computed tomography) scan and this was done using an ultrasound device but they did not have an available one for review.According to them it was not possible to say that the device contributed to the death and the doctor did not say so.

• Brand Name: COOL-TIP
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15321504
• MDR Text Key: 298898751
• Report Number: 1717344-2022-01043
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFA2030
• Device Catalogue Number: RFA2030
• Device Lot Number: 12360137X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2022
• Date Device Manufactured: 07/12/2021
• 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
• Treatment: RFAGEN COOL-TIP (SERIAL NUMBER: (B)(6).
• Patient Outcome(s): Death; Required Intervention
• Patient Sex: Female