MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Model Number	A-FASE-DF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.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 a pulmonary vein isolation procedure in the left atrium, the roof was punctured resulting in a pericardiocentesis being performed.An echocardiogram was performed and confirmed the puncture.The blood was drained from the pericardial sac.The patient was stable at the end of the procedure.The physician alleges the ablation catheter as the cause for the cardiac perforation.There were no performance issues with any abbott device.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿
• Common Device Name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
• 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: 24319176
• Report Number: 3008452825-2026-00040
• Device Sequence Number: 10213364
• Product Code: OAD
• UDI-Device Identifier: 05415067020062
• UDI-Public: (01)05415067020062(10)9090741(17)260531
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P110016
• 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): 02/11/2026

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: 05/31/2026
• Device Model Number: A-FASE-DF
• Device Catalogue Number: A-FASE-DF
• Device Lot Number: 9090741
• 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: 01/20/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2023
• 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
• Patient Sex: Unknown