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

Model Number	32041-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Fever (1858); Pain (1994)
Date of Event	07/08/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: circumferential balloon-based radiofrequency ablation for ultralong and extensive flat esophageal squamous neoplasia source: gastrointestinal endoscopy, volume 80, article 6, (1185-1189), 2014, date of publication: 08-july-2014.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Adults with diagnosis of high-grade dysplasia (3) and mucosal squamous cell carcinomas (7) underwent circumferential ablations.Four of the 7 patients had a history of head and neck cancers, and 4 had a history of cirrhosis.All patients had lesions that occupied more than half of the circumference of the esophagus, and 3 patients had circumferential extension.Patients underwent primary ablations circumferentially using the halo360 system (concomitant products energy generator, and a sizing balloon).All patients underwent circumferential rfa with a double-ablation regimen (12 j/cm2¿ clean ¿ 12 j/cm2).After endoscopic ablation, patients were provided with esomeprazole 40 mg/day and sucralfate suspension 5 ml (200 mg/ml) 4 times daily for 1 month.Acetaminophen and an oral narcotic were prescribed as needed.Patients logged postablation symptoms to record chest pain, throat pain, odynophagia and dysphagia.Patients received follow-up endoscopy with image enhancing modalities, including lugol staining and narrow-band imaging.This was performed 1, 3, and 6 months after the procedure and every 6 months thereafter.If residual squamous intraepithelial neoplasms were detected during follow-up endoscopy, focal ablation with the halo90 system (12 j/cm2, 2 applications) or argon plasma coagulation with competitor product.After primary circumferential rfa, 4 patients had residual squamous neoplasias.After additional therapy with focal rfa or apc, 6 of the 7 achieved a complete response at 6 months.One patient was not a candidate for additional ablation because of repeat variceal bleeding and poor results during the follow-up period.One patient who had cirrhosis, an intramural hematoma developed during the procedure.However, this resolved spontaneously without the need for further treatment.Two patients had fever after the procedure and were successfully treated with antibiotics.Chest and throat pain were the most frequent post-rfa symptoms.These developed in all patients and improved 7 days after the procedure.Esophageal strictures/stenosis developed in 2 of the 7 patients and required treatment with balloon dilation for 2 and 8 sessions, respectively.

• 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: 7839491
• Report Number: 3004904811-2018-00025
• Device Sequence Number: 16441152
• Product Code: GEI
• UDI-Device Identifier: 10884521189324
• UDI-Public: 10884521189324
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2018

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: 32041-25
• Device Catalogue Number: 32041-25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/31/2018
• 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: Required Intervention
• Patient Age: 54 YR