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

Model Number RFAGEN

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

Patient Problems Pulmonary Embolism (1498); Chest Pain (1776); Pulmonary Emphysema (1832); Fistula (1862); Hematoma (1884); Hemorrhage/Bleeding (1888); Hemothorax (1896); Hyperbilirubinemia (1903); Pleural Effusion (2010); Pneumothorax (2012); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440); Retroperitoneal Hemorrhage (4483); Unspecified Hepatic or Biliary Problem (4493)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

This product is not sold in us and is 510(k) exempt.Title: factors associated with local tumor control and complications after thermal ablation of colorectal cancer liver metastases: a 15-year retrospective cohort study source: clinical colorectal cancer, vol.20, no.2, e82-95.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective study identified incidence and risk factors associated with local tumor control and complications following percutaneous thermal ablation of colorectal cancer liver metastases.Between (b)(6) 2003 and (b)(6) 2017, 286 patients with 378 thermal ablation procedures were included in this study.Of these, cool tip rf electrodes were used in 110 of 213 procedures.Emprint mwa was used in 39 of 165 procedures.415 tumors were treated in 378 procedures.Post procedural major complications included: intrahepatic biloma (6), biliary stenosis (3) hyperbilirubinemia (3), bilioenteric/biliogastric fistula (2), extrahepatic biloma with infection and bile leak (1), arterioportal fistula (2), hepatic pseudoaneurysm and hematoma (3), retroperitoneal hematoma (1), bleeding (1), pulmonary embolism (2), pneumothorax and pleural effusion (2), svc thrombosis syndrome (1), hemothorax (1), pleural effusion (1), diaphragm injury (1), pneumothorax with pneumomediastinum, pneumoperitoneum and subcutaneous emphysema (1) for a total of 33 major complications.Post procedural minor complications included: biloma (7) hyperbilirubinemia/transaminase toxity (1) intrahepatic hematoma (6) portal vein injury/thrombosis (2) arteriovenous fistula (1) perihepatic bleeding during ablation (1) pneumothorax (17) pleural effusion (4) asthma exacerbation (1) non cardiac chest pain (5), post ablation syndrome (3).It is unknown whether the complications were related or associated with our devices.

• 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: 12585143
• MDR Text Key: 275129304
• Report Number: 1717344-2021-01362
• 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: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFAGEN
• Device Catalogue Number: RFAGEN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2021
• 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: 60 YR