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	Tachycardia (2095)
Date of Event	04/24/2024
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The patient had a concomitant surgical procedure of aortic valve replacement, coronary artery bypass graft surgery (cabg) through sternotomy.During the same procedure on the (b)(6) 2023) a cryoflex probe powered by a cryoconsole, and a cardioblate lp clamp powered by a cardioblate generator were used.The left atrial appendage was closed.The left pulmonary vein (lpv) and right pulmonary vein (rpv) conduction block were not performed as the patient was in atrial fibrillation.On the (b)(6) 2024) the patient experienced non-sustained ventricular tachycardia.On the (b)(6) 2024 the patient outcome status was recovered/resolved.The adverse event was deemed by the site as possibly related to the cardioblate bp2 clamp, the cryoflex probe, the study procedure, the concomitant procedure and the study device.The rationale for relating to the concomitant procedure: myocardial ablation disturbance and cardiac manipulation.The rationale for relating the adverse event to the device: myocardial ablation injury possible.
Additional Manufacturer Narrative
Correction b5: the patient had a concomitant surgical procedure of aortic valve replacement, coronary artery bypass graft surgery (cabg) through sternotomy.During the same procedure on the ((b)(6) 2023) a cardioblate bp2 device and a cryoflex probe were used.The left atrial appendage was closed.The left pulmonary vein (lpv) and right pulmonary vein (rpv) conduction block were not performed as the patient was in atrial fibrillation.On the ((b)(6) 2024) the patient experienced non-sustained ventricular tachycardia.On the (b)(6) 2024 the patient outcome status was recovered/resolved.The adverse event was deemed by the site as possibly related to the cardioblate bp2 clamp, the cryoflex probe, the study procedure, the concomitant procedure and the study device.The rationale for relating to the concomitant procedure: myocardial ablation disturbance and cardiac manipulation.The rationale for relating the adverse event to the device: myocardial ablation injury possible.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 ; 091708096
• MDR Report Key: 19631213
• Report Number: 3008592544-2024-00053
• Device Sequence Number: 8793249
• Product Code: OCL
• UDI-Device Identifier: 00763000114626
• UDI-Public: 00763000114626
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 07/15/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2024
• Device Model Number: 60SF3
• Device Catalogue Number: 60SF3
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/15/2024
• Date Device Manufactured: 09/22/2022
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White