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

Model Number	64082
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Premature Separation (4045)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during two times radiofrequency ablation (rfa) in the esophagus after barrett carcinoma for eradication of barrett (9 centimeter), lege artis.In each case in three steps, every four centimeter from proximal to distal, during the sixth and last radiofrequency ablation, the electrode partially detached from the self-expanding balloon catheter and was not rewrapped onto the balloon upon balloon deflation, so that the rolled-up electrode came to lie next to the deflated balloon.Immediately afterward, slight oozing bleeding of the esophagus was observed, which, however, was not necessarily attributable to the dysfunction, as it could also be expected per se after twice-performed radiofrequency ablation.The catheter was carefully removed from the esophagus to resolve the issue.There was no evidence of perforation.
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.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that the catheter was received with the electrode improperly furled.The electrode was not torn and was fully attached to the balloon.The connector pins were intact.Functional testing noted that the balloon was manually inflated with a syringe and able to hold pressure.The catheter electrically erasable programmable read-only memory (eeprom) data was read and there were no observed errors.The catheter was connected to a generator and recognized as used.A test catheter was used and the complaint device was able to inflate and hold pressure as expected.It was reported that the 360/sizing catheter detached from balloon.The reported issue could not be confirmed.The most likely cause could not be established from the information available.It was also reported that the 360/sizing catheter failed to return to parallel position.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: rotation of the device in a clockwise direction may reduce the device diameter and aid in removal.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.

• Brand Name: BARRX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LLC; 3062 bunker hill lane; santa clara CA 94085 4022
• Manufacturer (Section G): COVIDIEN LLC; 3062 bunker hill lane; santa clara CA 94085 4022
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22337019
• Report Number: 3004904811-2025-00036
• Device Sequence Number: 9060274
• Product Code: GEI
• UDI-Device Identifier: 10884521581876
• UDI-Public: (01)10884521581876(17)271219(10)B000003382(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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 Model Number: 64082
• Device Catalogue Number: 64082
• Device Lot Number: B000003382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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 Age: 69 YR
• Patient Sex: Male