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	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, the advisor hd grid x catheter became entangled with the ablation catheter.When attempting to move the advisor hd grid x catheter to the ripv, it would not maneuver.At this time a magnetic sensor issue appeared.On x-ray, it could be seen that when the diagnostic catheter was moved, so was the ablation catheter.The ablation catheter was then pulled back into the sheath, freeing it from the diagnostic catheter.The catheters were separated and the advisor hd grid x catheter was removed.There were no withdrawal difficulties noted once separated.The advisor hd grid x catheter was checked and no visible damage was noted.The diagnostic catheter was then reinserted and the cables were reseated with no resolution.The advisor hd grid x catheter was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One bi-directional, curve d-f, sensor enabled, advisor hd grid x mapping catheter was received for evaluation.The paddle assembly was found bent and damaged.Evidence in the event description shows that the ifu was not followed by the user.Advisor hd grid x instructions for use (ifu) artmt600333031 ver.A state, "do not use force to advance or withdraw catheter when resistance is encountered." in addition, the ifu also 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24492174
• Report Number: 3008452825-2026-00086
• Device Sequence Number: 5016991
• Product Code: MTD
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/14/2026

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: 11153767
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2025
• 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 Age: 44 YR
• Patient Sex: Female
• Patient Weight: 88 KG