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

Model Number	49341
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pulmonary Edema (2020); Lactate Dehydrogenase Increased (4567); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/15/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 or Problem Description
The patient had a concomitant surgical procedure of aortic valve replacement and cabg (number of anastomoses: 3) through sternotomy.The patient also had an aortic endarterectomy.During the same procedure a cryoflex probe powered by a cryoconsole, and a cardioblate lp clamp powered by a valleylab ft-10 generator were used.The left atrial appendage was successfully closed.Left pulmonary vein (lpv) and right pulmonary vein (rpv) conduction block was successfully achieved.One day after the procedure, the patient experienced multisystem organ failure, which was treated with an implantable pacemaker, additional medication, a right ventricular device, renal replacement therapy, and a surgical intervention.The patient died four days later.It was reported that the patient continued to have increased lactate levels post surgery.On post-op day 1, a right ventricular device was inserted.Urine output decreased over next 24 hours.Post-op day 2, they received renal replacement therapy.Post-op day 3, they had an external pacemaker implanted for loss of underlying rhythm.The patient continued to have increased lactate, hypotension, and severe pulmonary edema.They had worsening metabolic acidosis.They had multisystem organ failure and was deemed not to benefit from left ventricular support or a mitral valve repair.The adverse event was deemed by the sponsor as possibly related to the procedure and the concomitant procedure, but not related to the study devices.Medtronic received additional information that the adverse event was deemed by the site as possibly related to the concomitant procedure, unlikely related to the procedure but not related to the study devices.Medtronic received additional information that the event that resulted in patient death was assessed by site as unlikely related to the study procedure, possibly related to the concomitant procedure and possibly related to the study devices.Medtronic received additional information that the adverse event is updated as related to the device.It was reported that the rv failure was unlikely related, and the complication was related to the surgery in general, not the ablation component.
Additional Manufacturer Narrative
Medtronic received additional information that the site rationale for relating the ae to the procedure is possible chf related low output state ¿ edema.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.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: CARDIOBLATE
• Common Device Name: 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: 17779874
• Report Number: 2184009-2023-00944
• Device Sequence Number: 6551518
• Product Code: OCL
• UDI-Device Identifier: 00643169998018
• UDI-Public: 00643169998018
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2024
• Device Model Number: 49341
• Device Catalogue Number: 49341
• Device Lot Number: 699D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 11/23/2023
• Date Device Manufactured: 03/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White