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	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrial fibrillation procedure, impedance and output issues resulted in a procedural delay.Frequent "surface electrode impedance error" messages began to appear sometime after validation.The alert screen did not indicate which patch was faulty.The wiring and connections were checked and reconnected, and several revalidations were performed in an attempt to clear the alert, but the issue persisted.The system reference patch was replaced, and the impedance error was cleared.However, during pre-mapping in navx mode, intermittent noise began to appear on the respiration meter, while the ventilator¿s capnometer remained stable.The patch connection was checked.At the same time, the catheter¿s navigation display became distorted.By the end of the pre-mapping, the respiration meter was filled with noise, and the catheter¿s navigation display continued to move erratically.As the issue could not be resolved, the system was switched to voxel mode and the advisor hd grid mapping catheter was exchanged for the advisor hd grid x catheter.This stabilized the navigation display, but the respiration meter continued to show noise.Mapping was created in voxel mode, and the procedure was completed with no adverse consequences to the patient.However, the malfunction and the resulting troubleshooting measures caused the procedure to be delayed by approximately one hour.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.Electrodes 1-18 met specifications for acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22680319
• Report Number: 3008452825-2025-00383
• Device Sequence Number: 15844299
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: (01)05415067028198(10)10733180(17)280131
• 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
• Report Date (Section B): 08/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: D-AVHD-DF16
• Device Catalogue Number: D-AVHD-DF16
• Device Lot Number: 10733180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/04/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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
• Patient Sex: Unknown