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

Model Number	CTRF220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930); Liver Damage/Dysfunction (1954); Pain (1994); Pneumothorax (2012); Thrombosis/Thrombus (4440); Biliary Leak (4820)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to literature source of retrospective study performed between february 2013 and may 2021, the long-term outcomes of rfa using cool-tip rfa for peribiliary and non-peribiliary hcc using propensity score matching (psm), 282 patients were included in this retrospective study.Complications included intrahepatic bile duct dilatation (18), biloma formation (1), biliary fistula (1), liver decompensation (55), thrombus in peritumoral vessel (10), pain requiring treatment (19), infection (14), hydropneumothorax requiring drainage (3).Biloma formation and biliary fistula were treated with percutaneous biliary drainage.
Additional Manufacturer Narrative
Radiofrequency ablation for peribiliary hepatocellular carcinoma: propensity score matching analysis | jin cui, xinzi sui, kaiwen liu, min huang, yuanwenzheng, xinya zhao, gongzheng wang and ximing wang.| cui et al.Insights into imaging (2025) 16:45 | https://do i.Org/10.1186/s13244-025-01919-5.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: COOL-TIP
• 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: 22293714
• Report Number: 3004904811-2025-00035
• Device Sequence Number: 8271242
• Product Code: GEI
• UDI-Device Identifier: 10884524002781
• UDI-Public: 10884524002781
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K973297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2025

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: CTRF220
• Device Catalogue Number: CTRF220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/19/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 58 YR
• Patient Sex: Male