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	Improper or Incorrect Procedure or Method (2017); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Hemorrhage/Blood Loss/Bleeding (1888); Heart Block (4444)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a pulmonary vein isolation procedure, air embolism occurred during the saline solution exchange when the saline bag finished.The air was introduced because the flush of the new saline bag was done with the irrigation connected to the patient.There were two irrigations, one for the advisor hd grid catheter and one for tactiflex catheter.The advisor hd grid stopcock was closed instead of the tactiflex irrigation.At the start, a 2:1 block occurred, that became a complete block, and finally fv.An ecmo was used to maintain the blood circulation.Medication was administered.The patient recovered rhythm but a hemorrhage was detected and the patient was sent to a ct scan.The hemorrhage was a belly hematoma that occurred from resuscitation.The ct scan could not find the exact origin of the belly hematoma.Patient is recovering in the icu with ventricular disfunction and an extensive hematoma in the belly.The physician alleges the error in the interchange of the saline bag contributed to the air embolus.There were no performance issues with any abbott devices.
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 air embolism and air in the device 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24324317
• Report Number: 3008452825-2026-00044
• Device Sequence Number: 15833646
• Product Code: OAE
• UDI-Device Identifier: 05415067034571
• UDI-Public: 05415067034571
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 02/12/2026

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
• 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: 01/15/2026
• Initial Report FDA Received Date: 02/12/2026
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown