MAUDE Adverse Event Report: COVIDIEN GENERATOR RADIOFREQUENCY; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number RFG3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Thrombosis (2100)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient had great saphenous vein (gsv) treated using a closurefast device and rfg3 radiofrequency generator.Tumescent infiltration was used.Local anesthesia was used and compression was applied by hand.The procedure is reported to have been completed without any issue.The vein is reported to have closed.72 hours post procedure, the patient was sent to the emergency room (er) for stat computed tomography angiography (cta) which showed positive pulmonary embolism (pe.The patient was started on eliquis.One week post procedure, ultrasound revealed class i endothermal heat induced thrombosis (ehit).At this time the physician does not suspect the closurefast catheter to be a contributory cause.No further injury reported.

Manufacturer Narrative

Additional information: the customer has two rfg3¿s onsite.It is unknown which rfg3 the patient was treated with.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

Additional information: patient is maintained on eliquis and followed by pulmonology for the pulmonary embolism.The class i endothermal heat induced thrombosis is now resolved.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

Product analysis: the radio frequency generator was received into medtronic investigation lab for evaluation.Initial inspection of the unit revealed no physical anomalies.The device was powered on, passing post.After this the history and treatment data was downloaded and sent to engineering for decryption.The device then went through a 12 hour burn in phase using a rfg20-215 100ohm load, power was set to 8 watts and max voltage to 30volts.During this time no errors were produced.The device then went through and passed functional testing.An internal inspection was performed, no physical anomalies were found.No functional fault was found with the unit during testing.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: GENERATOR RADIOFREQUENCY
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10161827
• MDR Text Key: 195368539
• Report Number: 2183870-2020-00175
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521713444
• UDI-Public: 10884521713444
• Combination Product (y/n): N
• PMA/PMN Number: K141858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RFG3
• Device Catalogue Number: RFG3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 05/29/2020; 07/20/2020; 09/25/2020
• Supplement Dates FDA Received: 06/17/2020; 07/22/2020; 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 90