MAUDE Adverse Event Report: COVIDIEN LP BARRX BARRX; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	GW-002B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Laceration(s) of Esophagus (2398); No Code Available (3191)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a radio frequency ablation of barrett's esophagus following a balloon ablation of a proximal segment of esophagus, there was a bleeding on the 9:00 wall of the esophagus.After successfully removing the catheter without incident, the physician irrigated and inspected the bleeding area and there appeared to be an esophageal tear on the 9:00 wall of the esophagus.After continued inspection and irrigation, the bleeding stopped.It was determined that hemoclips were not needed.The physician decided to discontinue the procedure.

• Brand Name: BARRX
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 8466944
• Report Number: 3004904811-2019-00017
• Device Sequence Number: 1341561
• Product Code: KNT
• UDI-Device Identifier: 10884521189454
• UDI-Public: 10884521189454
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K935198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GW-002B
• Device Catalogue Number: GW-002B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1