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 Code	Cardiac Perforation (2513)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the supraventricular tachycardia, a pericardial effusion was noted which resulted in a pericardiocentesis being performed and open-heart surgery.The patient had a left lateral pathway so a transseptal approach was performed.The tactiflex catheter was advanced to the left atrium and the pathway was mapped to the most lateral aspect of the mitral valve.After ablation, the patient's blood pressure dropped and respirations became shallow.Ice was reviewed and a pericardial effusion was noted.A pericardiocentesis was performed and some blood was extracted but the patient's blood pressure and respirations did not respond.Open-heart surgery was then elected to be performed.The patient was then sent to the icu.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
Model/lot number information was not able to be obtained for this device.Therefore, full udi information(d4) and 510k(g3) are not available.
Additional Manufacturer Narrative
Additional information: d4, d9, g3, h2, h3, h4, h6, h11.One bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled was received for evaluation.When the returned device was connected to the tactisys quartz unit, optical fibers 1-3 met specifications for optical properties and contact force was displayed with no error messages noted.The catheter shaft deflected in both directions when the steering mechanism was actuated and met specifications for curve shape.No anomalies were noted on the eeprom payloads.Electrodes 1-4, both thermocouples and the magnetic sensors met specifications during electrical testing with no open or short circuits detected.The temperature reading of both thermocouples increased with exposure to heat.In addition, no leaks were detected during leak testing and the catheter met specifications for flow rate testing.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event of a pericardial effusion remains unknown.

• 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: 24423277
• Report Number: 3008452825-2026-00079
• Device Sequence Number: 5939955
• Product Code: OAE
• UDI-Device Identifier: 05415067034571
• UDI-Public: (01)05415067034571(10)11132608(17)281031
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 11132608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2025
• 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; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 130 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White