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

Model Number UNKNOWN COOL TIP ELECTRODE

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

Patient Problems Pneumothorax (2012); Sepsis (2067)

Event Date 10/21/2021

Event Type  Death  

Manufacturer Narrative

Title: thermal ablation combined with transarterial chemoembolization for hepatocellular carcinoma: what is the right treatment sequence? source: european journal of radiology 144 (2021) 110006 available online 26 october 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective study from 2009 to 2020 analyzed the effectiveness of different combinations of thermal ablation (radiofrequency ablation or microwave ablation) and transarterial chemoembolization (tace) for the treatment of hepatocellular carcinoma (hcc) in 38 patients.Radiofrequency ablation was performed with cool tip radiofrequency ablation system or competitor rfa device and microwave ablation was performed with emprint system or competitor device.Reported complications included one patient with pneumothorax who was treated with a chest tube placement.After follow-up tace procedure and despite antibiotics and percutaneous drainage the patient died from sepsis related to e.Coli peritonitis and hepatorenal syndrome.It is unclear which ablation device was used for the thermal ablation and it is also unclear whether the peritonitis was caused by the thermal ablation treatment or subsequent tace treatment that occurred one day after thermal ablation.

• Brand Name: UNKNOWN COOL TIP ELECTRODE
• 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: 14598448
• MDR Text Key: 293332465
• Report Number: 1717344-2022-00683
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN COOL TIP ELECTRODE
• Device Catalogue Number: UNKNOWN COOL TIP ELECTRODE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2022
• 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 Outcome(s): Death