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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a redo atrial fibrillation and atrial tachycardia procedure, a pericardial effusion was noted, resulting in a pericardiocentesis and open heart surgery being performed.After mapping the left and right atrium with the advisor hd grid x catheter, the tactiflex was moved from the left to the right atrium to start ablation.Before any ablation was delivered in the heart at all, hypotension occurred and a pericardial effusion was noted on trans-esophageal echo.A pericardiocentesis was started with some external shocks administered for ventricular tachycardia.Amiodarone, protamine and platelets were administered.As the tamponade was still not controlled, a decision was made to open the chest by the surgical team.The surgical team investigated the heart, no perforation site was found, and the bleeding was controlled so no intervention was needed to control the tamponade.As the patient was scheduled to have a reminiscent gap closure on a previously closed left atrial appendage, this was performed by the surgical team at this time.The patient was stable at the end of the procedure and sent to an intensive care ward for observation and recovery.The location and cause of the tamponade was not identified.There were no performance issues with any abbott devices.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.The results of the investigation are inconclusive since the device was not returned for analysis.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident of a pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• 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: 24111526
• Report Number: 3008452825-2026-00015
• Device Sequence Number: 13362154
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: D-AVHDX-DF16
• Device Catalogue Number: D-AVHDX-DF16
• Device Lot Number: 10921978
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 04/15/2026; Not provided
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 04/15/2026; 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female