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

Model Number	1190A-115A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Laceration(s) of Esophagus (2398); Radiation Exposure, Unintended (3164)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the catheter had kinked coils after the first pass and it caused lacerations in cervical esophagus.It was noted that the generator displayed an error code, but they were unable to recall the specific code.There were no loose components and the software was not upgraded.It was determined that the laceration in the cervical esophagus (between c7 and t1) occurred after the first set of ablation, probably due to the lack of clockwise turn on the removal of the catheter.The balloon did not look deflated.When the physician went back with the scope, the laceration was then noticed.The doctor and the technician were not aware of the correct procedure to follow.The barett¿s esophagus was 4 cm long with no dysplasia.The patient still complained of some odynophagia after discharge and was kept on liquid diet.The laceration was not clipped but was monitored by the physician with a ct scan.The patient will be seen, and the assistance of a representative was requested and scheduled.There patient was stable and will be rescheduled in 3 months.There was no user harm.

• 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: 8450061
• Report Number: 3004904811-2019-00011
• Device Sequence Number: 3056904
• Product Code: GEI
• UDI-Device Identifier: 10884521177796
• UDI-Public: 10884521177796
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K092487
• 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): 03/25/2019

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: 1190A-115A
• Device Catalogue Number: 1190A-115A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/25/2019
• 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