MAUDE Adverse Event Report: MEDTRONIC, INC. CRYOFLEX SURGICAL ABLATION PROBE; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING

Model Number	60SF3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	09/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank, because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The patient had a concomitant surgical procedure of mitral valve repair.Through a minimally invasive /thoracotomy approach.During the same procedure on (on (b)(6) 2024), a cryoflex probe powered by a cryoconsole and a cardioblate lp clamp powered by a valleylab ft10 generator were used.The left atrial appendage was successfully closed.Left pulmonary vein conduction block (lpv) was not performed, due to thoracotomy surgical approach and right pulmonary vein (rpv) conduction block was successfully achieved.On the ((b)(6) 2024), the patient experienced junctional rhythm.The patient with new junctional rhythm was in the intensive care unit (icu) after the index procedure.Antiarrhythmic medications was being held, due to it being contraindicated with junctional rhythm.The adverse event was deemed by the sponsor as not related to the concomitant procedure or the study devices and related to the study procedure.Medtronic received, additional information, that the adverse event was deemed by the site as possibly related to the cryoflex probe, the study procedure and the concomitant procedure.It was stated, that the adverse event was possibly related to the study procedure, due to the spread of the cryo lesions in right atrium (ra).And it was possibly, related to the mitral valve repair, due to the annuloplasty sutures.It was stated, that the adverse event is possibly, related to the cryoflex probe, due to the spread of the cryo lesions in the ra, because the rf probe does not articulate.The patients outcome status is recovering/resolving.
Additional Manufacturer Narrative
Medtronic received additional information that the adverse event is possibly related to the study device due to the spread of cryo lesions in the right atrium (ra) because the rf probe does not articulate.It was also stated that the adverse event is possibly related to the study device due to the spread of cryo lesions in the right atrium (ra) because the rf probe does not articulate, this could not be used due to small mini thoracotomy incision because the jaw of the rf probe does not articulate.Therefore, the cryo probe was used for ra.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CRYOFLEX SURGICAL ABLATION PROBE
• Common Device Name: SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353 091708096
• MDR Report Key: 20556962
• Report Number: 3008592544-2024-00090
• Device Sequence Number: 14259110
• Product Code: OCL
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K191526
• 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,Followup,Followup
• Report Date (Section B): 08/27/2026

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: 04/16/2026
• Device Model Number: 60SF3
• Device Catalogue Number: 60SF3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 11/01/2024; 08/14/2026; 08/14/2026
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/21/2024; 08/27/2026; 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2024
• 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: Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 218 LB