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	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.
Event or Problem Description
During the supraventricular tachycardia/atrial ventricular procedure, after mapping the right atrium, the physician attempted to remove the catheter through the non-abbott sheath (versacross by boston scientific) but was unable to pull the catheter back into the sheath.After some troubleshooting, the physician determined that one of the other diagnostic catheters had become entangled in the splines of the advisor hd grid x mapping catheter, preventing it from entering the sheath.The physician was eventually able to remove all catheters, and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
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) (b)(4) 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." review of the batch record was not possible as the lot number is unknown.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: 23507281
• Report Number: 3008452825-2025-00576
• Device Sequence Number: 9021237
• Product Code: MTD
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 11/09/2025
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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