MAUDE Adverse Event Report: COVIDIEN LP BARRX UNKNOWN BARRX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number UNKNOWN BARRX

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

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Fever (1858); Hemorrhage/Bleeding (1888); Stenosis (2263)

Event Date 12/06/2022

Event Type  Injury  

Manufacturer Narrative

Title: predictive factors of radiofrequency ablation failure in the treatment of dysplastic barrett¿s esophagus.Source: clinics and research in hepatology and gastroenterology 47 (2023) 102065 available online 6 december 2022.Simon weiss, anna pellat, felix corre, einas abou ali, arthur belle, benoit terris, mahaut leconte, anthony dohand, stanislas chaussade, romain coriat, maximilien barret.Https://doi.Org/10.1016/j.Clinre.2022.102065.D10: concomitant product: unk-barrx 360, unknown barrx 360 (lot#unknown); unk halo360, unknown halo 360 (lot#unknown).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 study, a single-center retrospective study from a prospectively collected database from 2011 to 2020, 96 patients were treated with four radiofrequency ablation procedure.For the 96 patients analyzed, there were three gastrointestinal bleedings during the follow-up period.There was only one with grade iii gastrointestinal bleeding, which occurred seven days after a treatment session, was directly attributable to radiofrequency ablation treatment which required hospital admission and endoscopic treatment, but no blood transfusion.Two patients reported severe and disabling chest pain (grade i) for up to seven days after radiofrequency ablation.One patient presented with isolated fever after a radiofrequency ablation session, with spontaneous resolution.Fourteen patients presented with post-radiofrequency ablation esophageal strictures (grade iii).Of these, two were diagnosed endoscopically while patients did not suffer from dysphagia.The remaining twelve strictures causing dysphagia were then treated by hydrostatic dilatation, with clinical success in all cases after a median dilatation for patients.

• Brand Name: UNKNOWN BARRX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• 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: 17297951
• MDR Text Key: 318864374
• Report Number: 3004904811-2023-00010
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN BARRX
• Device Catalogue Number: UNKNOWN BARRX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2023
• 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
• Treatment: PLEASE SEE NOTE ON H10
• Patient Outcome(s): Hospitalization; Required Intervention