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-X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Vascular Dissection (3160)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a pulmonary vein isolation atrial fibrillation procedure, the patient experienced st elevation in the precordial leads after ablating with a tactiflex se catheter.After delivering ablation, two mics of isuprel were administered to try to induce pvc's post-ablation.At this time, the patient began expressing discomfort and chest pain.Fentanyl was administered by anesthesia for the pain.It was noted that no obvious changes were observed, but upon review of the case slight st elevation was noted in some of the precordial leads.During this point of the case, the physician looked at the lv on ice and noted that the septal wall and apex of the left ventricle were no longer contracting.Cath lab physicians were called in and confirmed occlusion near the proximal ostia of the left anterior descending artery with contrast and fluoroscopy.During the cath portion of the procedure, the patient went into ventricular tachycardia and had to be shocked via external defibrillators.Intravascular ultrasound was brought in, and a dissection of the proximal left anterior descending artery was confirmed.A stent was placed, and the patient's septal wall of the left ventricle began contracting again with confirmation on ice.The patient¿s left ventricle apex was still not contracting at the time of case end, but the patient left the lab otherwise in stable condition and was admitted overnight.
Additional Manufacturer Narrative
The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.

• 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, Costa Rica Ltda (AFD); 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 ; +1(651)756-5400
• MDR Report Key: 50938840
• Report Number: 3008452825-2026-00529
• Device Sequence Number: 13446655
• Product Code: OAE
• UDI-Device Identifier: 05415067051998
• UDI-Public: 05415067051998
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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-X
• Device Catalogue Number: A-TFSE-DF-X
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 72 YR
• Patient Sex: Male