MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER UNKNOWN RF ELECTRODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number UNKNOWN RF ELECTRODE

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

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Pleural Effusion (2010); Rupture (2208); Unspecified Tissue Injury (4559)

Event Date 07/12/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the literature, a retrospective study assessed the complications associated with radiofrequency ablation (rfa) in the treatment of hepatic hemangioma between 2009 and 2019.It was noted that cooltip act2025 or actc1525 electrodes and rf generator were used for the rfa procedure.There were 304 lesions treated in 291 patients and complications included: 4 patients had bleeding at the puncture site treated with conservative management; 3 patients had tumor rupture which led to blood loss of 600 ml, 900 ml and 1,400 ml with hemostasis achieved by rfa under laparoscopy or open rfa as well as transfusion and rehydration therapy; 5 patients experienced lung injury and 4 patients had a diaphragmatic injury treated with conservative management and thoracoscopic surgery in one patient; one patient had a lower esophageal fistula treated with conservative management; and, one patient had a moderate pleural effusion treated with plural puncture drainage and diuretic therapy.Complications of radiofrequency ablation for hepatic hemangioma: a multicenter retrospective analysis on 291 cases, 12 july 2021, frontiers in oncology (novel insights into the treatment of hcc and liver tumors), shilun wu.

Manufacturer Narrative

Complications of radiofrequency ablation for hepatic hemangioma: a multicenter retrospective analysis on 291 cases accepted: 12 july 2021 source: frontiers in oncology (novel insights into the treatment of hcc and liver tumors) volume 11, article 706619 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: UNKNOWN RF ELECTRODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 12653352
• MDR Text Key: 277096148
• Report Number: 1717344-2021-01428
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN RF ELECTRODE
• Device Catalogue Number: UNKNOWN RF ELECTRODE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention