MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECTRODE

Model Number UNKNOWN COOL TIP ELECTRODE

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

Patient Problems Abscess (1690); Fever (1858); Fistula (1862); Hematoma (1884); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/03/2018

Event Type  Injury  

Event Description

According to the literature, the purpose of the study was to evaluate safety, time to recurrence, and overall survival in patients with liver metastases, treated with transarterial chemoembolization (tace) followed by ablation from august 1998 to september 2015.They used multiple ablation techniques and devices wherein one of which, included radio frequency ablation system with cool-tip.There were 42 patients treated for 44 liver metastases.Complications occurred in 19 patients (45%).Major complications occurred in 19% of patients and included 2 patients were hospitalized for fever (grade c), 3 patients had hepatic abscess and 1 patient for each of the following complications: fall requiring transfusion, portal vein thrombus causing lobar infarct, biliary fistula, and retroperitoneal hematoma.

Manufacturer Narrative

Title: combined chemoembolization and thermal ablation for the treatment of metastases to the liver source: abdom radiol (2018) 43:2859¿2867 published online: 3 march 2018.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN COOL TIP ELECTRODE
• 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: 13951503
• MDR Text Key: 288267761
• Report Number: 1717344-2022-00377
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN COOL TIP ELECTRODE
• Device Catalogue Number: UNKNOWN COOL TIP ELECTRODE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male