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

Model Number	64082
Medical Device Problem Codes	Difficult to Remove (1528); Premature Separation (4045)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the spring-tipped guidewire was advanced to the antrum and the scope was withdrawn.The catheter was advanced over a wire and across the ge junction.Two radiofrequency ablations were performed.The scope was withdrawn.There was mild resistance removing the catheter and wound withdrawn, the ablation coil had detached partially from the balloon.On repeat inspection, there was a small mucosal injury noted in the proximal esophagus/ues region.There was self-limited oozing.This was carefully examined the aid of the distal attachment cap and no deep injury was suspected.Given this finding, no additional ablation was performed.

• Brand Name: BARRX
• Common Device Name: 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21464329
• Report Number: 3004904811-2025-00016
• Device Sequence Number: 3652861
• Product Code: GEI
• UDI-Device Identifier: 10884521581876
• UDI-Public: 10884521581876
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K142364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/25/2025

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 Expiration Date: 01/01/1999
• Device Model Number: 64082
• Device Catalogue Number: 64082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown