MAUDE Adverse Event Report: COVIDIEN LP BARRX UNKNOWN BARRX 360; Electrosurgical, cutting & coagulation & accessories

Model Number UNKNOWN BARRX 360

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

Patient Problems Arrhythmia (1721); Atrial Flutter (1730); Chest Pain (1776); Dyspnea (1816)

Event Date 08/09/2023

Event Type  Injury  

Manufacturer Narrative

Title: atrial flutter after radiofrequency ablation for barrett¿s esophagus: a case report source: atrial flutter after radiofrequency ablation © | am j case rep, 2023; 24: e941264 | alessia fassari, vito de blasi, marco basile and silvana perretta | published: 2023.10.05 | https://www.Amjcaserep.Com/abstract/inde x/idart/941264 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 literature, a case study presented a 74-year-old male patient who was referred to the hospital for treatment of barrett¿s esophagus.In (b)(6) 2021, non-circumferential radiofrequency ablation using the barrx halo90 was performed to achieve local control of the dysplastic area.During the two-hour post-procedure monitoring, a 12-lead electrocardiogram revealed type i atrial flutter.The patient exhibited well-tolerated dyspnea, and monitoring was continued using serial electrocardiograms and a 24-hour holter monitor.Atrial flutter was initially treated by intravenous amiodarone followed by a switch to oral administration, which restored sinus cardiac rhythm.Two days post procedure, the patient experienced a recurrent atrial flutter episode with more pronounced symptoms, including palpitations, chest pain and dyspnea.Medical treatment proved to be ineffective, and an external electrical cardioversion was necessary to restore sinus cardiac rhythm.The patient was discharged on antiarrhythmic treatment.Atrial flutter ablation and two additional radiofrequency procedures were performed to treat barrett¿s esophagus.Endoscopic control in (b)(6) 2022 revealed lower esophageal ulceration, and a laparoscopic nissen fundoplication was performed.Endoscopic follow-ups were normal with complete eradication of barrett¿s esophagus.

• Brand Name: UNKNOWN BARRX 360
• Type of Device: Electrosurgical, cutting & coagulation & accessories
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• Manufacturer (Section G): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18358698
• MDR Text Key: 330932346
• Report Number: 3004904811-2023-00019
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: LU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN BARRX 360
• Device Catalogue Number: UNKNOWN BARRX 360
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male