MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	A-FASE-DF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At the end of a wpw procedure in the ra with the ensite x system and the flexability ablation catheter, the patient experienced an st elevation.A coronary angiography was performed and a stent was implanted due to an occlusion of the posterolateral rca.The physician is unsure of the exact cause of the st elevation, potentially thermal trauma of the rf energy near the coronary sinus.The physician stated there was no malfunction of the catheter.The patient is in stable condition.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One bi-directional, curve d-f, flexability sensor enabled ablation catheter was received for evaluation.Electrodes 1-4, the magnetic sensor, and the thermocouple met specifications during electrical testing with no open or short circuits detected.In addition, the catheter met specifications during temperature testing and was able to be flushed.The batch record was re-viewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23796308
• Report Number: 3008452825-2025-00660
• Device Sequence Number: 10476967
• Product Code: OAD
• UDI-Device Identifier: 05415067020062
• UDI-Public: (01)05415067020062(10)11048080(17)280831
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P110016
• 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,Followup
• Report Date (Section B): 02/19/2026

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-FASE-DF
• Device Catalogue Number: A-FASE-DF
• Device Lot Number: 11048080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2025
• 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: Required Intervention; Life Threatening
• Patient Sex: Unknown