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

Model Number	90-9200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Gastrointestinal Hemorrhage (4476); Hematemesis (4478); Unintended Radiation Exposure (4565)
Type of Reportable Event	Death
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 physician used an ultra 90 catheter to treat a 1 cm segment of low dysplasia.The patient was on effient (blood thinner) but it was held 7 days prior to procedure.The ablations were performed with 1 tap ¿ clean ¿ 1 tap protocol given they used the ultra.The procedure was very short and extremely uneventful, no symptoms afterwards.There was not even any significant oozing after rfa (radiofrequency ablation) performed.There was no evidence of liver disease, and no varices on exam.The patient was discharged home on the typical regimen of sucralfate, bid ppi (twice a day, proton pump inhibitors) and viscous lidocaine as per our unit protocol following rfa.The patient was asymptomatic until 10 days after the rfa, when the patient developed acute onset hematemesis (vomiting of blood).The patient had to resume effient around a week after the procedure due to cardiac comorbidities.The patient was admitted to an outside hospital for the gastrointestinal bleed and initial egd showed presence of large amount of blood in the esophagus, but nothing actively bleeding.The patient was embolized by ir (interventional radiology) and follow up egd showed ulcers at the distal esophagus without any stigmata and no bleeding.It was confirmed that there was no significant overlap between ablation hit locations and the energy density used was 12 for the ultra, they left the setting at the default.It was learned that the patient died 10 days after the procedure was done.

• Brand Name: BARRX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 12181065
• Report Number: 3004904811-2021-00011
• Device Sequence Number: 19070568
• Product Code: GEI
• UDI-Device Identifier: 10884521189379
• UDI-Public: 10884521189379
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 90-9200
• Device Catalogue Number: 90-9200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/16/2021
• 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: Death; Hospitalization; Required Intervention