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

Model Number	D-AVSE-D10-F20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Heart Block (4444)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, while mapping, av block occurred which was treated with stimulation to stabilize the patient.The patient was sedated with dexdor and mapping was performed using both the tacticath se catheter and the advisor fl se catheter.Towards the end of the mapping the patient went into complete av block.Stimulation was administered in the coronary sinus with the catheter and after a few seconds sinus rhythm was restored.A cardiogram was done which was negative.The patient was unable to be awakened so ct and mri exams were done which were also negative.The patient woke up the next day and ct scans were repeated and again were negative.The physicians do not think that any abbott products are involved in the reported event.No ablations had been performed prior to the reported av block.There were no performance issues with any abbott device.
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 could not be conclusively determined.
Event or Problem Description
This report includes an updated event description and updated health clinical code and health impact code.During an atrial fibrillation procedure, while mapping, av block occurred which was treated with stimulation to stabilize the patient.The patient was sedated with dexdor and mapping was performed using both the tacticath se catheter and the advisor fl se catheter.Towards the end of the mapping the patient went into complete av block with st segment elevation in the absence of hemodynamic lesions on coronary imaging.Stimulation was administered in the coronary sinus with the catheter and after a few seconds sinus rhythm was restored.A cardiogram was done which was negative.The patient was unable to be awakened and developed a coma, so ct and mri exams were done which were negative.The patient was admitted to icu and gradually recovered consciousness the next day.Ct scans were repeated, and an ischemic encephalic lesion appeared with concurrent motor deficit of the upper limb.The physicians do not think that any abbott products are involved in the reported event.No ablations had been performed prior to the reported av block.There were no performance issues with any abbott device.

• Brand Name: ADVISOR¿ FL, CIRCULAR MAPPING CATHETER, SENSOR ENABLED¿
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE 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): ST. JUDE 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: 22202557
• Report Number: 3008452825-2025-00257
• Device Sequence Number: 7722982
• Product Code: DRF
• UDI-Device Identifier: 05415067024817
• UDI-Public: (01)05415067024817(10)10612752(17)271031
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/17/2025

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 Model Number: D-AVSE-D10-F20
• Device Catalogue Number: D-AVSE-D10-F20
• Device Lot Number: 10612752
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2024
• 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