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

Model Number	64082
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the brand-new catheter appeared used upon opening.It had a reddish-brown substance inside the packaging.There was no patient involvement.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and photos were available for evaluation.Visual inspection noted dried reddish brown discoloration in the packaging.The seal transfer zone of the sterile packaging was broken.The connector pins were intact.The electrode was not torn.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) was read and e95 and c52 errors were observed.This indicates the product had been used.Two previous activations were recorded in catheter eeprom.A test catheter was connected to the rf output cable and the received device was able to inflate properly and hold pressure.It was reported that there was blood in the unopened packaging.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: errors were recorded in the device eeprom.One e95 air leak was recorded.A c52 error which indicates the catheter max usage time had been reached.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.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 & ACCES
• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24400595
• Report Number: 3004904811-2026-00003
• Device Sequence Number: 18606488
• Product Code: GEI
• UDI-Device Identifier: 10884521211599
• UDI-Public: (01)10884521211599(17)280318(10)B000003508(20)01
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: B000003508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• 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