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 Codes	Fracture (1260); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the ventricular tachycardia procedure, it was noted that the tip of the catheter became stuck in the tip of the non-abbott sheath (cordis 8f).The sheath and catheter had to be removed together.Once it was removed from the patient, the tip of the catheter was noted to be fractured.The catheter was exchanged, and the procedure was completed with no adverse consequences to the patient.The physician confirmed no part of the catheter remained in the patient.
Additional Manufacturer Narrative
Additional information: g3, h2, h6, h11.Two images were submitted for evaluation to product performance engineering; no product was received.The images returned shows the paddle of the advisor to have been fractured and detached.Evidence in the event description shows that the ifu was not followed by the user.Advisor hd grid x instructions for use (ifu) state, "do not use force to advance or withdraw catheter when resistance is encountered." in addition, the ifu also states, "the catheter is compatible with an 8.5f minimum introducer sheath." the batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the event 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: 24248372
• Report Number: 3008452825-2026-00048
• Device Sequence Number: 8309072
• Product Code: MTD
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 06/01/2026

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 Expiration Date: 06/30/2026
• Device Model Number: D-AVHDX-DF16
• Device Catalogue Number: D-AVHDX-DF16
• Device Lot Number: 10933246
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 05/13/2026; 06/01/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 05/27/2026; 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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: 28 YR
• Patient Sex: Unknown