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

Model Number	D-AVHD-DF16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	09/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model/lot number information was not able to be obtained for this device.Therefore, full udi information(d4) and 510k(g3) are not available.
Event or Problem Description
At the end of a pulsed field ablation procedure for atrial fibrillation, with the advisor hd grid catheter in the atrium for post mapping, the patient suddenly became arrested.Cardiac massage had to be started immediately after using the viewmate for the echocardiogram.The procedure was completed without replacing the device and there were no adverse consequences to the patient.There were no alleged performance issues with any abbott devices.
Additional Manufacturer Narrative
Additional information: d4, g3, h2, h3, h4.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.An event of cardiac arrest was reported.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.

• Brand Name: ADVISOR¿ HD GRID 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: 23230544
• Report Number: 3008452825-2025-00499
• Device Sequence Number: 9757931
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: (01)05415067028198(10)10888030(17)280531
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• 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 Model Number: D-AVHD-DF16
• Device Catalogue Number: D-AVHD-DF16
• Device Lot Number: 10888030
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 10/01/2025; 01/14/2026
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 10/30/2025; 02/11/2026
• 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
• Patient Sex: Unknown