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

Model Number ACT2020

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

Patient Problem Pleural Effusion (2010)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

Title assessment of radiofrequency ablation efficacy for hepatocellular carcinoma by histology and pretransplant radiology source liver transplantation, volume 25, 2019 (88-97) article number: 1 date of publication: 19 october 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study performed january 2007 to december 2016, this study aimed at evaluating the histologic response after rfa of small hccs arising in cirrhosis.Data were reviewed from 78 patients with de novo early-stage hepatocellular carcinoma (hccs) who were treated with rfa and subsequently transplanted.Percutaneous rfa was performed using a cool-tip single needle (cool-tip radiofrequency electrode; radionics, minneapolis, usa) having a length of 20 cm with an exposed tip of 2 or 3 cm.The length of the exposed tip used depended on the tumor dimensions.The total number of rfa sessions was 92.During these sessions, 14 patients had some complications for a total of 18 (19.6%) events, but only 1 infectious complication graded as 3 (definable as major) occurred, returning a major complication rate of only 1.1%.Details are reported in table 4; grade 1-2 pleural effusion= 3.Notably, most of the complications were graded as minor, and morbidity in ablated patients having the largest tumor >3 cm was significantly higher (35.0%) than that of patients having the largest treated tumor =3 cm (9.7%; p = 0.01).No needle tract seeding among 125 treated nodules was detected.Authors noted that the data demonstrate the safety of the ablative procedure and are in keeping with the literature, and even in some instances, lower than the reported morbidity.Please refer to the attached full text for further details.

• Brand Name: COOL-TIP
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 8410363
• MDR Text Key: 138553679
• Report Number: 1717344-2019-00312
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524001210
• UDI-Public: 10884524001210
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• 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
• Date Manufacturer Received: 02/15/2019
• 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