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

Model Number	65CS1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	10/05/2024
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 minimally invasive thoracotomy.During the same procedure on the ((b)(6) 2024) 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) was not performed due to the thoracotomy surgical approach.The right pulmonary vein (rpv) conduction block was successfully achieved.On the ((b)(6) 2024) the patient experienced sinus node dysfunction.Sinus node dysfunction (bradycardia) with av block vs blocked premature atrial contractions (pacs) was noted on telemetry while admitted from the index procedure.Antiarrhythmic medications being held due to contraindication with rhythm.A pacemaker was inserted.The patients outcome status was recovering/resolving.The adverse event was deemed by the site as possibly related to the cardioblate lp clamp, the cryoflex probe, the concomitant procedure, the study procedure and the study device.The adverse event was deemed by the sponsor as possibly related to the cardioblate lp clamp, the cryoflex probe and the cardioblate cryoflex console and related to the concomitant procedure and study procedure.
Additional Manufacturer Narrative
Medtronic received additional information that the adverse event is possibly related to the study device due to the rf prob not articulating the jaw and it is difficult to use in mini thoracotomy cases.Hence, the cryo probe had to be used for lesions.The rf probe could not be used for ras lesions, therefore the cryo probe was used.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: CRYOCONSOLE
• 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: 20512744
• Report Number: 3008592544-2024-00087
• Device Sequence Number: 7203844
• Product Code: OCL
• UDI-Device Identifier: 00763000014988
• UDI-Public: 00763000014988
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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
• Operator of Device: Health Professional
• Device Model Number: 65CS1
• Device Catalogue Number: 65CS1
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/21/2024
• Date Device Manufactured: 07/23/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 99 KG