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

Model Number	60SF2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, ascending aorta replacement, maze and left atrial appendage (laa) ligation procedure through sternotomy.During the same procedure on (b)(6) 2022 a cryoflex probe powered by a cryo-console, and a cardioblate lp clamp powered by an ft-10 generator were used.The left atrial appendage was stapled.Left pulmonary vein (lpv) and right pulmonary vein (rpv) conduction block were achieved.Patient had been in junctional rhythm during the procedure and switched to ventricular paced rhythm, the next day on (b)(6) 2022.Patient switched back to junctional rhythm and stayed that way for 5 days until (b)(6) 2022.  event was treated with medication and percutaneous intervention.The patient recovered.The adverse event was deemed by the sponsor as not related to the cryoflex probe, cardioblate lp clamp or ft-10 generator and related to the study procedure, concomitant procedure and cryo-console instrument.Medtronic received additional information that the adverse event was deemed by the site as possibly related to concomitant procedure, study procedure, cryoflex probe, and the cardioblate lp clamp.

• 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 ; 091708096
• MDR Report Key: 16032949
• Report Number: 3008592544-2022-00082
• Device Sequence Number: 15259935
• Product Code: OCL
• UDI-Device Identifier: 00763000114619
• UDI-Public: 00763000114619
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123733
• 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
• Report Date (Section B): 12/22/2022

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: 11/11/2022
• Device Model Number: 60SF2
• Device Catalogue Number: 60SF2
• 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: 12/09/2022
• Initial Report FDA Received Date: 12/22/2022
• Date Device Manufactured: 12/01/2020
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White