MAUDE Adverse Event Report: PERFUSION SYSTEMS CARDIOBLATE; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING

Model Number 49260

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

Patient Problems Arrhythmia (1721); Stroke/CVA (1770); Fistula (1862); Hematoma (1884); Inflammation (1932); Transient Ischemic Attack (2109); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 02/26/2015

Event Type  Injury  

Manufacturer Narrative

Beukema rj, adiyaman a, smit jjj, delnoy pphm, ramdat misier ar, elvan a.Catheter ablation of symptomatic postoperative atrial arrhythmias after epicardial surgical disconnection of the pulmonary veins and left atrial appendage ligation in patients with atrial fibrillation.Eur j cardiothorac surg 2016;49:265¿71.Doi:10.1093/ejcts/ezv047 no unique device identifier (serial/lot) numbers were provided.Patient codes (ime/annex e).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding minimally invasive thorascopic epicardial pulmonary vein isolation (mipi) in the surgical treatment of atrial fibrillation.All data was collected from a single center between may 2006 and february 2012.The study population included 41 patients (predominantly male; mean age 58 years), who underwent ablation with a medtronic irrigated bipolar rf ablation clamp [cardioblate] (serial numbers not provided).Among all patients, adverse events included: temporary phrenic nerve palsy, pleuropericarditis, tamponade requiring pericardial drainage, tia 5 days after surgery, recurrent atrial arrhythmias, cerebrovascular accident, groin haematoma, femoral arteriovenous fistula requiring thrombin injection, and cardiac perforation.Based on the available information, these adverse events may have been associated with medtronic product.No product performance issues or additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic investigation the complaint devices were requested for analysis but no response was received from the customer, so medtronic are unable to determine if there were any device issues associated with the reported events.We are also unable to determine a root cause for the reported issues, based on the information available.Through review of the available information it was determined that these issues were most likely procedure-related and not related to the device itself.If a complaint device or additional information is received, a complete analysis will be completed and the complaint file will be updated.Medtronic will continue to monitor for future events.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

Medtronic received information via literature regarding minimally invasive thorascopic epicardial pulmonary vein isolation (mipi) in the surgical treatment of atrial fibrillation.All data was collected from a single center between may 2006 and february 2012.The study population included 41 patients (predominantly male; mean age 58 years), who underwent ablation with a medtronic irrigated bipolar rf ablation clamp [cardioblate] (serial numbers not provided).Among all patients, adverse events included: temporary phrenic nerve palsy, pleuropericarditis, tamponade requiring pericardial drainage, tia 5 days after surgery, recurrent atrial arrhythmias, cerebrovascular accident, groin haematoma, femoral arteriovenous fistula requiring thrombin injection, and cardiac perforation.Based on the available information, these adverse events may have been associated with medtronic product.No product performance issues or additional adverse patient effects were reported.

• Brand Name: CARDIOBLATE
• Type of Device: SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 11566942
• MDR Text Key: 242672833
• Report Number: 2184009-2021-00014
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• PMA/PMN Number: K121767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 49260
• Device Catalogue Number: 49260
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR