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	Heart Block (4444)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a concomitant surgical procedure of aortic valve replacement, coronary artery bypass graft (cabg) through sternotomy.During the same procedure on the ((b)(6) 2023) a cryoflex probe and a cardioblate lp clamp were used.The left atrial appendage was successfully closed.The left pulmonary vein (lpv) and right pulmonary vein (rpv) conduction block were not performed as the patient was in atrial fibrillation.On ((b)(6) 2023) the patient experienced complete heart block.The patient was treated with an implantable cardiac rhythm device.The pacemaker was implanted to treat the complete heart block that the patient developed post-surgery.The adverse event was deemed by the site as unlikely related to the cryoflex probe and the cardioblate lp clamp, possibly related to the concomitant procedure and the study procedure.The rationale for relating to the concomitant procedure is that the heart block is possibly related to ablation.The rationale for relating to the adverse event is that it is unlikely related.The adverse event was deemed by the sponsor as not related to the cryoflex probe, the cardioblate clamp or the study procedure and related to the concomitant procedure.The patients outcome status was recovered/resolved on the (b)(6) 2023.
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.
Additional Manufacturer Narrative
Additional information b5.Medtronic received additional information that the rationale for relating the adverse event to the device is unlikely as ablation with the clamp is far from conduction anatomy.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.
Additional Manufacturer Narrative
Medtronic received additional information that on the (b)(6) 2023 the patient experienced complete heart block.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: 19481094
• Report Number: 3008592544-2024-00045
• Device Sequence Number: 12774434
• Product Code: OCL
• UDI-Device Identifier: 00763000114626
• UDI-Public: 00763000114626
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2024

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: 05/29/2024
• Supplement Date Received by Manufacturer: 08/12/2024; 11/21/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 08/30/2024; 11/25/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White