MAUDE Adverse Event Report: ABBOTT MEDICAL ADVISOR¿ FL, CIRCULAR MAPPING CATHETER, SENSOR ENABLED¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D-AVSE-DF10-F15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	12/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, during geometry collection with an advisor fl catheter, the patient became hypotensive and a cardiac tamponade was noted.It is unknown how and when the cardiac tamponade occurred.A pericardiocentesis was performed and the patient was stable at the end of procedure and the day after.
Event or Problem Description
During an atrial fibrillation procedure, during geometry collection with an advisor fl catheter, the patient became hypotensive and a cardiac tamponade was noted on ultrasound.It is unknown how, when, and where the cardiac tamponade occurred.A pericardiocentesis was performed and the patient was stable at the end of procedure and the day after.There were no alleged performance issues with any abbott devices.
Additional Manufacturer Narrative
Additional information: b5, g3, h2, h3, h6, h11.The reported cardiac tamponade could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: ADVISOR¿ FL, CIRCULAR MAPPING CATHETER, SENSOR ENABLED¿
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 24190579
• Report Number: 3008452825-2026-00025
• Device Sequence Number: 15894405
• Product Code: DRF
• UDI-Device Identifier: 05415067025975
• UDI-Public: (01)05415067025975(10)10913972(17)280531
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K202066
• 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): 03/19/2026

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: D-AVSE-DF10-F15
• Device Catalogue Number: D-AVSE-DF10-F15
• Device Lot Number: 10913972
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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: Required Intervention
• Patient Sex: Unknown