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

Model Number 49341

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

Patient Problem Stroke/CVA (1770)

Event Date 08/25/2022

Event Type  Injury  

Manufacturer Narrative

¿this report is being submitted as part of a retrospective review and remediation for capa 564121 per (b)(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.

Event Description

The patient had a concomitant surgical procedure of mitral valve repair through a minimally invasive thoracotomy.During the same procedure on (b)(6) 2022) a cryoflex probe powered by a cryo-console, and a cardioblate lp clamp powered by a valley lab ft-10 generator were used.The left atrial appendage was successfully sutured closed.Left pulmonary vein (lpv) conduction block was not performed (d/t minimally invasive port access approach) and right pulmonary vein (rpv) conduction block was successfully achieved.Approximately 15 days post procedure (b)(6) 2022) the patient experienced acute infarct of right parietooccipital.Patient c/o dizziness and ear fullness x4 days.Sent to hospital by pcp for head ct, in which results indicated acute infarct of right parieto-occipital lobe.Inr therapeutic.The adverse event was deemed by the site as not related to the study devices or study procedure, but possibly related to the concomitant procedure.The adverse event was deemed by the sponsor not related to the study devices, but related to the study procedure and concomitant procedure.The adverse event was deemed by the cec as possible related to the cryoflex probe, cardioblate clamp, study procedure and concomitant procedure but not related to the cryo-console.Comments from cec: stated that a non disabling ischemic stroke was confirmed on mri and the devices could have caused a blood clot if the anticoagulation was not appropriately done.Medtronic received additional information that the adverse event was deemed by the site as possibly related to the study procedure and study devices.The site provided the following rationale for relating the adverse event to the devices: cerebrovascular accident is a known potential risk of the devices.

• 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: 18684558
• MDR Text Key: 335113531
• Report Number: 2184009-2024-00076
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2022
• Device Model Number: 49341
• Device Catalogue Number: 49341
• Device Lot Number: 836C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 02/12/2024
• Date Device Manufactured: 10/30/2019
• 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): Hospitalization; Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White