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 Bradycardia (1751); Cardiac Arrest (1762); Ventricular Fibrillation (2130)

Event Date 08/07/2023

Event Type  Injury  

Manufacturer Narrative

Tian shu, caijie shen, xiaomin chen, and fei yu "two severe complications post-percutaneous intramyocardial septal radiofrequency ab lation in a patient with failed alcohol septal ablation: pulseless electrical activity cardiac arrest and pericardial tamponade¿a case report" european heart journal - case reports (2023) 7.Https://doi.Org/10.1093/ehjcr/ytad371.Pages 1-4.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.

Event Description

According to a case study published in literature, a 72 year old female with hypertrophic obstructive cardiomyopathy was treated with transthoracic echocardiography (tte)-guided percutaneous intramyocardial septal radiofrequency ablation (pimsra) using cool-tip rfa.The patient became bradycardic with ventricular escape beats and went into pea cardiac arrest which was treated with 20 minutes of cpr and veno-arterial extracorporeal membrane oxygenation support.The ablation resulted in malignant myocardial tissue edema.Due to radiofrequency ablation conducting thermal heat to deeper tissue, expansion of edema could potentially increase the risk for mortality.The patient survived this off label use of the cool-tip device.

• 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: 18126285
• MDR Text Key: 327999940
• Report Number: 1717344-2023-01394
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/21/2023
• 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): Other; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female