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

Model Number	64082
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	11/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: radiofrequency ablation for barrett¿s oesophagus related neoplasia with the 360 express catheter: initial experience from the united kingdom and ireland¿preliminary results source: surgical endoscopy https://doi.Org/10.1007/s00464-021-08325-0 received: 29 june 2020 / accepted: 13 january 2021 © the author(s) 2021.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to literature source of study performed november 2015 to november 2017, radio-frequency ablation (rfa) for barrett¿s oesophagus (be)-related neoplasia was done to present real world data on the use of the 360 express catheter.The aim of this study was to retrospectively evaluate the efficacy and safety (in terms of stricture formation) of the 360 express rfa balloon catheter.There were 123 patients and 112 of them had a follow up endoscopy.The median age was 67 years.Out of 112 patients, 5 patients (15%) developed strictures requiring dilation.The primary outcome was the surface regression of barrett¿s oesophagus at 3 months as calculated by % change in circumferential.The 5 patients developed esophageal strictures that were symptomatic, and which required endoscopic dilation.The median number of dilations required to resolve was 2 and although 2 patients required 5 dilations, most were not refractory strictures and were therefore amenable to endoscopic balloon dilatation to allow alleviation of the resultant dysphagia.Secondary analysis was performed to assess if stricture formation was related to the treatment regimen used.The 12 j/cm2 energy setting was associated with significantly more strictures than the 10 j/cm2.The instruction for use (ifu) stated that the dosimetry and treatment protocol for the new device used in clinical practice should be 10 j/cm2 and that a cleaning phase a distal attachment cap followed by water irrigation should be performed when the device is used for the treatment of barrett¿s oesophagus.

• 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: 11627286
• Report Number: 3004904811-2021-00006
• Device Sequence Number: 14291961
• Product Code: GEI
• UDI-Device Identifier: 10884521211599
• UDI-Public: 10884521211599
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2021

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 Expiration Date: 01/01/1999
• Device Model Number: 64082
• Device Catalogue Number: 64082
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/07/2021
• 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