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

Model Number UNKNOWN COOL TIP ELECRTRODE

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

Patient Problems Abscess (1690); Fever (1858); Perforation (2001); Pneumonia (2011); Sepsis (2067); Thrombosis/Thrombus (4440); Gastrointestinal Hemorrhage (4476); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

Title: switching monopolar radiofrequency ablation improves long-term outcomes of medium-sized hepatocellular carcinoma source: european radiology (2021) 31:8649¿8661.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed from 2008 to 2014, a retrospective study to analyze outcomes of 139 patients with medium-sized hepatocellular carcinoma (hcc) treated with either switching monopolar radiofrequency ablation (sw-rfa) or single-monopolar radiofrequency ablation (s-rfa).Sw-rfa was performed using 3-4 cm covidien cool-tip ablation probes and s-rfa was performed with either the covidien cooled tip ablation probe or a competitor device.Major complications tallied with gastric varices bleeding (1 patient) , major intrabdominal bleeding (1pt), intrahepatic duct dilatation (1 pt), portal vein thrombosis (1 pt), liver abscess (2 pt), severe sepsis (1 pt), post ablation fever (55 pt), pneumonia (1 pt) and colon perforation (1 pt).Pli20: according to literature source of study performed from 2008 to 2014, a retrospective study to analyze outcomes of 139 patients with medium-sized hepatocellular carcinoma (hcc) treated with either switching monopolar radiofrequency ablation (sw-rfa) or single-monopolar radiofrequency ablation (s-rfa).Sw-rfa was performed using 3-4 cm covidien cool-tip ablation probes and s-rfa was performed with either the covidien cooled tip ablation probe or a competitor device.Minor complications with post ablation hemoglobin decrease >2 g/dl (6 patients), post ablation seroma (asymptomatic) (1 pt), minimal ascites (asymptomatic) (9 pts), and minor electrolyte imbalance (1 pt).

• Brand Name: UNKNOWN COOL TIP ELECRTRODE
• 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: 13935169
• MDR Text Key: 288085589
• Report Number: 1717344-2022-00361
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN COOL TIP ELECRTRODE
• Device Catalogue Number: UNKNOWN COOL TIP ELECRTRODE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male