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	Heart Block (4444)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a slow pathway modification procedure for typical avnrt, transient heart block occurred that recovered by the time the procedure was finished.When the tacti cath se ablation catheter was advanced toward a manual 3d his lesion in the right atrium to check for his signal following delivery of rf lesions for slow pathway modification, the patient entered complete heart block with a junctional escape.The complete heart block went unnoticed in the procedure for about 1 minute.Before the complete heart block was noted, two additional rf lesions were delivered in the slow pathway area, and slow junctional rhythms were observed during ablation.After the final lesion, the complete heart block was noted by the physician.The tacti cath se ablation catheter was removed from the slow pathway area and placed into the ivc to see if av synchrony would return.After a few minutes, the patient entered second degree 2:1 av block.The physician then administered isuprel.After the isuprel was stopped, the patient was still experiencing 2:1 av block.At this time, the physician removed all catheters from the body and declared the procedure to be over.As anesthesia began waking up the patient, av synchrony was restored and the patient was stable upon leaving the lab.
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 transient heart block remains unknown.

• 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: 23556064
• Report Number: 3008452825-2025-00589
• Device Sequence Number: 9764365
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: (01)05415067027641(10)10905084(17)280531
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 02/04/2026

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-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 10905084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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: Other
• Patient Age: 40 YR
• Patient Sex: Female