MAUDE Adverse Event Report: ABBOTT MEDICAL TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿; Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Model Number	A-TFSE-DF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Cardiac Arrest (1762); Vasoconstriction (2126)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident of st elevation, pea, and coronary spasm could not be conclusively determined.
Event or Problem Description
During the ventricular tachycardia procedure, hypotension occurred associated with st elevation, followed by pea with a transient response to inotropic support which resulted in resuscitation being performed and placement of a va-ecmo, and a coronary spasm treated with nitrates.The procedure was performed under general anesthesia in the setting of chronic ischemic structural heart disease with moderate-to-severe depression of left ventricular systolic function, in a patient with a history of percutaneous revascularization of the right coronary artery.Approximately 15 minutes after rf delivery was performed at the anterolateral lvot base under ice guidance, at a distance of at least 2 cm from the aortic root and with an exclusively endocardial approach, the patient developed hypotension with gradual hemodynamic deterioration associated with st-segment elevation, followed by pea with a transient response to inotropic support.Resuscitation maneuvers were initiated with escalation of catecholamine support, followed by placement of va-ecmo, and coronary angiography was performed, revealing diffuse coronary spasm that partially regressed with nitrates, in the absence of hematoma, dissection, or thrombosis on ivus.New st elevation.Occurred with evidence of sub-occlusion of the mid segment of the lad (likely spasm over a plaque), which was treated with multiple revascularizations.Partial recovery of left ventricular contractility followed, with return of a pulsatile waveform and aortic valve opening; therefore, ecmo support was continued at a reduced setting in the intensive care unit.The patient is currently stable.There were no performance issues with any abbott devices.

• Brand Name: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• Common Device Name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
• Manufacturer (Section D): ABBOTT MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ABBOTT MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24382378
• Report Number: 3008452825-2026-00046
• Device Sequence Number: 10504072
• Product Code: OAE
• UDI-Device Identifier: 05415067034571
• UDI-Public: (01)05415067034571(10)11006433(17)280731
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P220013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: A-TFSE-DF
• Device Catalogue Number: A-TFSE-DF
• Device Lot Number: 11006433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other; Life Threatening
• Patient Sex: Unknown