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	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a pvi atrial fibrillation procedure, while mapping, the advisor hd grid x catheter became caught in the tactiflex ablation catheter which was able to be removed without difficulty.The procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
One bi-directional, curve d-f, sensor enabled, advisor hd grid x mapping catheter was received for evaluation.No visual anomalies were noted.Advisor hd grid x instructions for use (ifu) states, "to prevent entanglement with concomitantly used catheters, use care when using during use of the catheter." the batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the device entanglement is consistent with not following the instructions for use.

• Brand Name: ADVISOR¿ HD GRID X¿ MAPPING CATHETER, SENSOR ENABLED¿
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 23863742
• Report Number: 3008452825-2025-00688
• Device Sequence Number: 10092281
• Product Code: MTD
• UDI-Device Identifier: 05415067049889
• UDI-Public: (01)05415067049889(10)11067042(17)280831
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 03/02/2026

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: 11067042
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• 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