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 Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
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 of an exposed spline could not be conclusively determined.
Event or Problem Description
During the atrial fibrillation procedure in voxel mode, when the catheter was removed from the patient, the wire on the b spline was noted to be exposed.The catheter was used for about two hours with no issues noted.Both the electric potentials and the positional information remained normal.There was no noticeable resistance during insertion or removal.The electrodes looked intact and the wire unbroken.The physician determined that there was no risk of any part remaining inside the body, and the procedure was completed without replacing the catheter.There were no adverse patient consequences.

• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23935095
• Report Number: 3005334138-2025-00776
• Device Sequence Number: 9627381
• Product Code: MTD
• UDI-Device Identifier: 05415067049889
• UDI-Public: (01)05415067049889(10)10976454(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
• Report Date (Section B): 12/31/2025

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-AVHDX-DF16
• Device Catalogue Number: D-AVHDX-DF16
• Device Lot Number: 10976454
• 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: 12/12/2025
• Initial Report FDA Received Date: 12/31/2025
• 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