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

Model Number	90-9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Laceration(s) of Esophagus (2398)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: standard versus simplified radiofrequency ablation protocol for barrett¿s esophagus: comparative analysis of the whole treatment pathway source: tan wei keith et al.Standard versus simplified¿ endoscopy international open 2020; 08: e189¿e195 date of publication: 22.01.2020.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pli 10: according to the literature source of the study performed between january 2007 and august 2017, 5 patients developed strictures and dilations was done after the radio frequency procedure.The comparison of two rfa protocols which was 1 non label ( standard) and 1 off label ( simplified) had multiple adverse event.10 patients developed esophageal strictures following rfa (1 patient in standard group and 9 patients in simplified group), which were classified by the authors as ¿complications from rfa¿.Strictures were dilated, with a median of 1 dilation session required.2 patients required >2 dilations (1 patient required 2 dilations, 1 patient required 7 dilations).The simplified protocol was associated with 11 times greater odds of developing strictures compared to the standard protocol.Type of rfa device was not associated with risk of stricture.Of the 12 patients that needed rescue-emr, 1 patient developed a stricture.2 patients treated with the standard protocol had serious adverse events as judged by the authors.1 patient had symptomatic atrial fibrillation within 36hr of two ablation sessions (1 circumferential and 1 focal) and needed pharmacological cardioversion.1 patient had severe chest pain and dysphagia within 48hr of rfa and was admitted, but this was not related to esophageal stricture and was managed with analgesia and iv fluids.1 patient treated with the simplified protocol had a serious adverse event.There was no evidence of active bleeding and the patient was observed for 24hr before being discharged.Article: standard versus simplified radiofrequency ablation protocol for barrett¿s esophagus: comparative analysis of the whole treatment pathway author: wei keith tan published online: 2020-01-22.

• Brand Name: BARRX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 10017031
• Report Number: 3004904811-2020-00010
• Device Sequence Number: 2167977
• Product Code: GEI
• UDI-Device Identifier: 10884521189362
• UDI-Public: 10884521189362
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 90-9100
• Device Catalogue Number: 90-9100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR