MAUDE Adverse Event Report: COVIDIEN LP BARRX BARRX 360; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number UNKNOWN BARRX 360

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

Patient Problem Stenosis (2263)

Event Date 09/27/2021

Event Type  Injury  

Manufacturer Narrative

Title: comparative outcomes of radiofrequency ablation and cryoballoon ablation in dysplastic barrett¿s esophagus: a propensity score matched cohort study source: 422 gastrointestinal endoscopy volume 95, no.3: 2022.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of a retrospective study performed from october 2014 to december 2020, 311 patients were identified, 226 underwent radiofrequency ablation (rfa) and 85 underwent cryoablation (cba) for the treatment of dysplastic/neoplastic barrett¿s esophagus.A catheter was used with the reported complication of esophageal strictures in 10 patients who underwent radiofrequency ablation and 9 patients who underwent cryoablation.All were successfully treated with endoscopy and esophageal dilation.

• Brand Name: BARRX 360
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• 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: 14431898
• MDR Text Key: 291976200
• Report Number: 3004904811-2022-00006
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN BARRX 360
• Device Catalogue Number: UNKNOWN BARRX 360
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2022
• 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): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male