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 Pulmonary Embolism (1498); Abscess (1690); Thrombosis/Thrombus (4440)

Event Date 04/09/2022

Event Type  Death  

Event Description

According to the literature, a prospective study from january 2010 to february 2021 analyzed outcomes of 449 patients with liver-only metastatic colorectal carcinoma who underwent open or percutaneous thermal ablation with either radiofrequency ablation (rfa) or microwave ablation (mwa).Rfa was performed with either the cool tip rfa system or competitor devices.Mwa was performed with either the evident or emprint system or competitor devices.The authors reported some deaths.One patient died from a massive pulmonary embolism 7 days after a combined liver resection and ablation procedure.Five others died from postoperative complications between 30 and 90 days.One patient died due to massive portal thrombosis and multi-organ failure 5 weeks after combined percutaneous ablation and irreversible electroporation, and three died due to abdominal abscesses and cardiopulmonary failure 8-9 weeks after combined liver resection and open ablation.The article did not specify which device was associated with the reported complications and deaths.

Manufacturer Narrative

Title: improved outcomes of thermal ablation for colorectal liver metastases: a 10-year analysis from the prospective amsterdam core registry (amcore) source: cardiovasc intervent radiol (2022) 45:1074¿1089 https://doi.Org/10.1007/s00270-022-03152-9 d10 concomitant prod: unk emprint ant unknown emprint antenna lot # unknown; unknown vt mwa unknown microwave disposable lot # unknown; unknown cool ti unknown cool tip elecrtrode lot # unknown; unk emprint ant unknown emprint antenna lot # unknown; unknown vt mwa unknown microwave disposable lot #unknown; unknown cool ti unknown cool tip elecrtrode lot # unknown; unk emprint ant unknown emprint antenna lot # unknown; unknown vt mwa unknown microwave disposable lot # unknown medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15592370
• MDR Text Key: 301623410
• Report Number: 1717344-2022-01277
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• 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
• Date Manufacturer Received: 09/22/2022
• 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
• Patient Sex: Male