MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number	4FC12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Tachycardia (2095); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id: afapro23 (24079)product type: balloon catheter product id: 2ach15 (b)(6) product type: mapping catheter product id: nitron (b)(6) product type: console 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
It was reported that during a pulmonary vein isolation procedure using the catheter afapro23 afa pro 23, the patient experienced st segment elevation after the first cryo ablation in the left inferior pulmonary vein.Freeze parameters were normal at -63 degrees for 180 seconds, and the onset of st segment elevation occurred 2 minutes and 45 seconds into the freeze.Interventional cardiology was contacted, and 10mg intravenous vasodilator medication was administered.The procedure was aborted under general anesthesia.Coronary angiography revealed completed occlusion of the right coronary artery and chronic coronary artery disease in the left main/left anterior descending arteries.The patient exhibited small runs of ventricular tachycardia and premature ventricular contractions, which were treated with 150mg of an antiarrhythmic medication.An interventionalist injected 300mcg intracoronary vasodilator medication into the aortic root/right coronary artery, which immediately resolved the st segment elevation.The event was diagnosed as acute coronary spasm.The patient was stable, transferred to the intensive care unit for medical management, and underwent a computed tomography surgery consult.No further patient complications have been reported as a result of this event.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22772134
• Report Number: 3002648230-2025-00726
• Device Sequence Number: 9585275
• Product Code: DRA
• UDI-Device Identifier: 00763000418052
• UDI-Public: (01)00763000418052(17)270416(10)0012741791
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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 Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0012741791
• 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: 07/23/2025
• Initial Report FDA Received Date: 08/11/2025
• Date Device Manufactured: 04/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 79 KG