MAUDE Adverse Event Report: ABBOTT MEDICAL TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	A-TCSE-DF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a premature ventricular contraction procedure, a pericardial effusion was noted after rf ablation lesions in the rvot and lvot that required pericardiocentesis.At the start of the procedure, a diagnostic catheter was used to create rv geometry and collect mapping data in the rv and rvot.A site of interest was identified, and the diagnostic catheter was removed from the patient.The ablation catheter was then advanced into the right atrium, and contact force was zeroed.Rf lesions were delivered at the site of interest in the rvot.The ablation catheter was removed from the rvot, retrograde aortic access was obtained, and the ablation catheter was advanced into the lvot where geometry and mapping data were collected and rf lesions were delivered.The ablation catheter was removed from the patient and placed back into the rvot.The ablation catheter was removed from the patient and the diagnostic catheter was advanced into the rvot where more mapping and geometry data were collected.A contact force error message displayed that required the ablation catheter to be replaced with a new ablation catheter.The new ablation catheter was used for the rest of the procedure, and more rf lesions were delivered in the rvot.After delivery of the last rf lesion, the catheter was moved laterally in the rvot, and an impedance of over 200 ohms was observed.Within a minute of this impedance change, there was a significant drop in the patient¿s blood pressure and the physician noted a pericardial effusion on ice surrounding the heart.All catheters were removed from the patient and a pericardiocentesis was performed.The patient¿s blood pressure was stabilized prior to leaving the lab.The patient was admitted to the unit for overnight observation and has since recovered and been discharged from the hospital.The patient did not have any known prior comorbidities.The physician alleges the second ablation catheter to be the cause of the pericardial effusion.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One bi-directional, curve d-f, tacticath sensor enabled contact force ablation catheter 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 magnetic sensor, both thermocouples, and electrodes 1-4 met specifications during electrical testing with no open or short circuits detected.In addition, the device met specifications during temperature testing, occlusion testing, and leak testing.The catheter shaft deflected in both directions when the steering mechanism was actuated and met specifications for curve shape.The device history 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.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F
• 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: 23688673
• Report Number: 3008452825-2025-00612
• Device Sequence Number: 12226069
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: (01)05415067027641(10)10558674(17)260331
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130026
• 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): 01/20/2026

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 Expiration Date: 03/31/2026
• Device Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 10558674
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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
• Patient Sex: Female