MAUDE Adverse Event Report: ABBOTT MEDICAL ADVISOR¿ HD GRID X¿ MAPPING CATHETER, SENSOR ENABLED¿; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number	D-AVHDX-DF16
Medical Device Problem Codes	Fluid/Blood Leak (1250); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrial fibrillation procedure, blood leaked from the valve of the sheath.The sheath was inserted through the right groin and advanced into the atrium.After the guidewire and dilator were removed, blood leakage was observed from the valve of the sheath.The sheath was replaced and the procedure was completed with no adverse consequences to the patient.
Event or Problem Description
It was originally reported that an introducer leaked blood.However, new information was received confirmed that no leak occurred for this event and that the correct device is an advisor hd grid x catheter.During the atrial fibrillation procedure, after the catheter was connected to the cable, it was not recognized on ensite.The cable replacement and reconnection were performed, but the issue was not resolved.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
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 of a recognition issue could not be conclusively determined.

• Brand Name: ADVISOR¿ HD GRID X¿ MAPPING CATHETER, SENSOR ENABLED¿
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24571489
• Report Number: 3005334138-2026-00121
• Device Sequence Number: 15811013
• Product Code: MTD
• UDI-Device Identifier: 05415067049889
• UDI-Public: (01)05415067049889(10)10976443(17)280630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K241372
• 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): 03/20/2026

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-AVHDX-DF16
• Device Catalogue Number: D-AVHDX-DF16
• Device Lot Number: 10976443
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 03/15/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• 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