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 Hemorrhage/Bleeding (1888); Great Vessel Perforation (2152); Cardiac Tamponade (2226)

Event Date 08/22/2022

Event Type  Injury  

Manufacturer Narrative

Literature details: authors: skala, tomas and cernícek, vlastimil and moravec, ondrej and vícha, marek and santavy, petr and steriovsky, andrea and skálová, jitka and klementová, o.And táborsky, milos title: electrophysiological findings after bilateral thoracoscopic atrial fibrillation ablation using irrigated bipolar radiofrequency energy - a pilot study journal- cor et vasa volume 64, 2022, pages 499-503, doi: 10.33678/cor.2022.055 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 thoracoscopic atrial fibrillation ablation (tarafs) using irrigated bipolar radiofrequency energy.All data were collected from a single center.The study population included 22 patients (predominantly male;mean age 62 years) all of which were treated with medtronic cardioblate gemini-s clamps (serial numbers not provided).Box isolation of la posterior wall was acutely achieved in 21 patients.In one patient, a severe pleural obliteration was found, precluding further ablation and the procedure was ended.20 patients had no complications during and after the surgery.One patient had urinary infection and a local inflammation at the place of central venous cannula.One patient developed cardiac tamponade early after surgery that led to reoperation.The source of bleeding was a defect in ascending aorta.After this reoperation, there were no additional issues and the patient recovered well.Based on the available information, the cardiac tamponade and associated re-operation for bleeding due to a defect in the ascending aorta may have been attributed to medtronic product.No direct correlation could not be made between the additional observed adverse events and medtronic product.Among all patients, no deaths occurred and there were no device malfunctions 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
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17689039
• MDR Text Key: 322698912
• Report Number: 2184009-2023-00924
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K121767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• 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): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male