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

Model Number ACT2020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Pleural Effusion (2010)

Event Date 11/22/2021

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 286566855
• Report Number: 1717344-2022-00258
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524001210
• UDI-Public: 10884524001210
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K973297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: ACT2020
• Device Catalogue Number: ACT2020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male