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 Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Cardiac Perforation (2513); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the atrial fibrillation procedure, a pericardial effusion occurred which required a pericardiocentesis.While performing brockenbrough, difficulty was noted and several attempts were needed to enter the left atrium.When the catheter was inserted into the left atrium and manipulated, the catheter could not be manipulated as expected.The catheter was removed from the patient, and when attempting brockenbrough again, a decrease in blood pressure was noted.Transthoracic echocardiography revealed no pericardial effusion, and there was no increase in the heart rate, so the patient was observed with vasopressors.The blood pressure rose momentarily and then gradually decreased, which occurred repeatedly.Each time this occurred, an echo was performed.After a while, pericardial effusion was diagnosed.The procedure was stopped and a pericardiocentesis was performed.It seemed that something had happened during brockenbrough.It was considered that the abbott devices including the reported device were not involved in the event.
Event or Problem Description
This report is to include an updated event description.During the atrial fibrillation procedure, a pericardial effusion occurred which required a pericardiocentesis.While performing brockenbrough with the non-abbott needle (nrg by boston scientific), difficulty was noted and several attempts were needed to enter the left atrium.When the catheter was inserted into the left atrium and manipulated, the catheter could not be manipulated as expected.It is thought this manipulation difficulty with the catheter was due to an issue with the position of the brockenbrough.The catheter was removed from the patient, and when attempting brockenbrough again, a decrease in blood pressure was noted.Transthoracic echocardiography revealed no pericardial effusion, and there was no increase in the heart rate, so the patient was observed with vasopressors.The blood pressure rose momentarily and then gradually decreased, which occurred repeatedly.Each time this occurred, an echo was performed.After a while, pericardial effusion was diagnosed.The procedure was stopped and a pericardiocentesis was performed.It seemed that something happened during brockenbrough.It was considered that the abbott devices were not involved in the event.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h2, h3, h6, h11.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the batch record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24449375
• Report Number: 3008452825-2026-00088
• Device Sequence Number: 16045660
• Product Code: OAE
• UDI-Device Identifier: 05415067034571
• UDI-Public: (01)05415067034571(10)11037257(17)280831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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 Model Number: A-TFSE-DF
• Device Catalogue Number: A-TFSE-DF
• Device Lot Number: 11037257
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2025
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown