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

Model Number 90-9100

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

Patient Problem Stenosis (2263)

Event Date 07/20/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient who underwent rfa (radiofrequency ablation) treatment of barrett's esophagus (roughly 7 cm) used the 90 focal device.The rfa procedure itself was relatively unremarkable.The patient developed stricture, and approximately three dilation sessions have already been attempted.The physician was interested on the information related to steroid therapy and/or stenting.

Manufacturer Narrative

Additional info: a2, a3, b5, g3, rfr code.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient who underwent rfa (radiofrequency ablation) treatment of barrett's esophagus (roughly 7 cm) used the 90 focal device.The rfa procedure itself was relatively unremarkable.The patient developed stricture, and approximately 3 dilation sessions have already been attempted.The patient had the stricture a few weeks after the case.The physician used a stentfor the stricture.The patient was now doing well from the stent.

• Brand Name: BARRX
• 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: 12828471
• MDR Text Key: 280950393
• Report Number: 3004904811-2021-00019
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521189362
• UDI-Public: 10884521189362
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90-9100
• Device Catalogue Number: 90-9100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2021
• 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: 60 YR
• Patient Sex: Male