MAUDE Adverse Event Report: COVIDIEN LP BARRX UNKNOWN BARRX

Model Number UNKNOWN BARRX

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

Patient Problem Stenosis (2263)

Event Date 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

Title: endoscopic radiofrequency ablation or surveillance in patients with barrett¿s oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial source: barret m, et al.Gut 2021;70:1014¿1022.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed between december 2010 and december 2014, they performed a prospective study comparing radiofrequency ablation (rfa) with endoscopic surveillance with the aim of assessing the efficacy of rfa for the endoscopic therapy of barrett¿s esophagus with low grade dysplasia.82 patients were included in this study 40 patients included in the rfa group and 42 patients in the surveillance group.Out of the 40 patients, 37 actually received the rfa treatment.At least one adverse event occurred in patients after rfa with a total of 22 patients with 1 patient included had esophageal stricture.It was unknown if the device deficiency contributed to the complication or if the events is a serious injury or required intervention.

• Brand Name: UNKNOWN BARRX
• 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: 12225169
• MDR Text Key: 265624479
• Report Number: 3004904811-2021-00012
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 07/06/2021
• 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 Age: 65 YR