MAUDE Adverse Event Report: ABBOTT MEDICAL TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿; Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Model Number	A-TFSE-D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
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.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 of a cardiac perforation could not be conclusively determined.
Event or Problem Description
During the premature ventricular contractions procedure, a cardiac perforation was noted which resulted in a pericardiocentesis being performed.The pvc procedure was in both the left and right ventricles.A non-abbott cs catheter (biosense) was placed and advanced anteriorly to see if there were any early ventricular signals.The tactiflex catheter with the agilis sheath were introduced into the right ventricle to map the pvc but no early points were found.Thus, it was decided to map the left ventricle.The left ventricle was accessed via femoral artery.The ablation catheter was then introduced into the left ventricle and it was hard to get to the target area, so it was decided to go transseptal to access the left ventricle.After transseptal access, the left ventricle was mapped, and an early area was found and ablated.The pvc went away.A secondary pvc was observed and it was decided to attempt to find it.This pvc was mapped on the right side and then the left.It was decided it was a perinodal pvc originating near the his.The aortic cusp area was about to be checked for signals when it was noticed that the pvc was gone and the sinus heart rate had increased.Using ice it was then observed that there was a moderate effusion behind the right atrium.A pericardiocentesis was performed to vacate the effusion.The patient stabilized and was sent to icu.Later the patient had to come back to place a different kind of drain and then left the lab in stable condition.The physician stated after the procedure that this happened on the right side of the heart but was unsure of what caused it or when it occurred.There were no performance issues with any abbott devices.

• 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: 24430592
• Report Number: 3008452825-2026-00083
• Device Sequence Number: 18698789
• Product Code: OAE
• UDI-Device Identifier: 05415067034656
• UDI-Public: 05415067034656
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 02/24/2026

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-D
• Device Catalogue Number: A-TFSE-D
• 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: 01/30/2026
• Initial Report FDA Received Date: 02/24/2026
• 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; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 61 KG