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

Model Number GW-002B

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

Patient Problems Laceration(s) of Esophagus (2398); No Code Available (3191)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 8466944
• MDR Text Key: 145795078
• Report Number: 3004904811-2019-00017
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521189454
• UDI-Public: 10884521189454
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GW-002B
• Device Catalogue Number: GW-002B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2019
• 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