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 Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was noted during an af procedure that a spline dissociated from the grid panel.When the physician went to retract the advisor hd grid from the patient, some resistance was felt and one spline was dissociated from the grid panel.The advisor hd grid was entrapped with the decapolar catheter (coronary sinus).The advisor hd grid was exchanged with another advisor hd grid and the issue resolved.The procedure was completed and there were no adverse patient consequences.
Additional Manufacturer Narrative
Additional information b5, d9, g3, g6, h2, h3, h6.One bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.The device was returned due to device entanglement.The paddle was found damaged.The damage is consistent with using force to withdraw the product.The product instructions for use warns do not use force to advance or withdraw catheter when resistance is encountered.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the damaged paddle and device entanglement is consistent with not following the instructions for use.
Event or Problem Description
It was noted during an af procedure that a spline dissociated from the advisor hd grid panel.When the physician went to retract the advisor hd grid from the patient, some resistance was felt and one spline was dissociated from the catheter panel.The advisor hd grid was entrapped with a decapolar catheter (coronary sinus).The advisor hd grid was exchanged with another advisor hd grid and the issue resolved.The procedure was completed and there were no adverse patient consequences.

• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23584583
• Report Number: 3008452825-2025-00596
• Device Sequence Number: 18467794
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: (01)05415067028198(10)10958966(17)280630
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/06/2026

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-AVHD-DF16
• Device Catalogue Number: D-AVHD-DF16
• Device Lot Number: 10958966
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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