MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	A-FASE-D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/16/2025
Type of Reportable Event	Death
Event or Problem Description
During a premature ventricular contraction ablation procedure, a tamponade occurred which required a pericardiocentesis and surgery.When the region of interest was assessed, a few applications were done at 40 watts and the patient experienced cardiogenic shock.Fluoroscopy and echocardiogram were performed which revealed a tamponade.A pericardiocentesis was performed followed by surgery to resolve the bleeding.The patient is in intensive care and on extracorporeal membrane oxygenation (ecmo).There were no performance issues with any abbott devices.
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 cardiac tamponade remains unknown.Per the ifu, vascular perforation is an inherent risk of any electrode placement.
Additional Manufacturer Narrative
Additional information: b2, b5, g3, h1, h2, h6.
Event or Problem Description
Additional information was received which noted that, shortly after the procedure, the patient was transferred to intensive care at a different facility for further treatment, but the patient expired.There were no performance issues with any abbott device, and the physician does not believe the flexability catheter contributed to the patient death.

• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22663883
• Report Number: 3008452825-2025-00379
• Device Sequence Number: 7626249
• Product Code: OAD
• UDI-Device Identifier: 05415067020031
• UDI-Public: (01)05415067020031(10)8930230(17)260228
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 10/15/2025

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: 02/28/2026
• Device Model Number: A-FASE-D
• Device Catalogue Number: A-FASE-D
• Device Lot Number: 8930230
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2023
• 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
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Unknown