MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER COOL-TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	ACT2020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Pleural Effusion (2010)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Title: feeding vessel ablation: a novel subsegmental devascularization technique for the treatment of hepatocellular carcinoma located at the liver marginal angle.Source: ultrasound in medicine <(>&<)> biology vol.48, no.3, pp.546553.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature, a prospective study from june 2014 to january 2016 evaluated the efficacy of feeding vessel ablation (fva) in the treatment of hepatocellular carcinoma (hcc) located in the liver marginal angle (lma) using a medtronic cool tip radiofrequency ablation electrode.Nine patients were included in the study with the following reported complications.Two patients had failed procedures (defined as having any tumor enhancement remaining after 18 min of fva or 3 cycles of ablation).These two patients were referred out for rescue therapy including repeated percutaneous ethanol injection or transarterial chemoembolization (tace).Other reported complications included one case of asymptomatic pleural effusion requiring no medical intervention and one case of moderate fever that was relieved within 48 hours after an unspecified treatment.

• Brand Name: COOL-TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 13666580
• Report Number: 1717344-2022-00258
• Device Sequence Number: 4659288
• Product Code: GEI
• UDI-Device Identifier: 10884524001210
• UDI-Public: 10884524001210
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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: ACT2020
• Device Catalogue Number: ACT2020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/04/2022
• 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: 55 YR
• Patient Sex: Male