MAUDE Adverse Event Report: COVIDIEN LP BARRX

Model Number UNK-BARRX

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

Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Stenosis (2263); Injury (2348)

Event Date 12/03/2017

Event Type  Injury  

Manufacturer Narrative

Title: article: massimiliano di pietro, united european gastroenterology journal 2018, vol.6(5) 662¿668.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed 2007 and 2017, nine patients required rescue emr (endoscopic mucosal resection) due to development of new nodular lesions after commencing the rfa (radiofrequency ablation).10 patients developed stricture following rfa (radiofrequency ablation) and they required dilation.One patient in the hgd (high-grade dysplasia) group developed atrial fibrillation during ablation necessitating cessation of the rfa (radiofrequency ablation).After a brief pause, the ablation was resumed and the procedure was completed.One patient developed delayed symptomatic atrial fibrillation 36 hours after two consecutive ablations which required hospital admission and pharmacological cardioversion.One patient required admission post procedure because of severe chest pain and total dysphagia.No stricture was noted for this patient during endoscopy.

• 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: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 9876131
• MDR Text Key: 196483518
• Report Number: 3004904811-2020-00004
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-BARRX
• Device Catalogue Number: UNK-BARRX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 68 YR