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	Difficult to Remove (1528); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During atrial fibrillation procedure, there was a thrombus noted at the end of the advisor hd grid x.Ultrasound imaging was performed prior to procedure to rule out any thrombus.After brockenbrough, left atrial mapping (premap) was performed using the sheath (abroad) and hd grid x from the right inguinal puncture site.During the initial pulmonary vein isolation using pfa, the reported catheter was removed from the body, and no thrombus was observed at that time.After the pulmonary vein was isolated using pfa (fara pulse), left atrium mapping (postmap) was performed using hd grid x.As the residual potential was confirmed in the right carina, an additional application using fara wave was performed.At the time of additional pfa, the hdg was placed in the right atrium.Mapping was not performed after the additional pfa, and the procedure was completed without replacing the catheter and there were no adverse consequences to the patient.When the physician removed the hdgridx from the patient¿s body, it was found that a 2×1 mm thrombus was on the tip of the a-1 paddle part.In addition, the physician stated that there was strong resistance to removal of hdgrid x from the sheath.Since two sheath had been used, the hd grid was inserted into each sheath to check push-pull resistance after the procedure, and resistance was found in only one of the sheaths, so the sheath was suspected as the cause.The hd grid had been irrigated with heparinized saline using a pressure bag.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One bi-directional, curve d-f, sensor enabled, advisor hd grid x mapping catheter was received for evaluation.One image was also submitted to product performance engineering for evaluation.No thrombus was noted on the returned device; however, the image submitted with the returned device shows a thrombus on the paddle assembly.No resistance or functional anomalies were noted when the catheter was advanced through a sheath assembly from current inventory.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the thrombus and reported withdrawal difficulty remains unknown.
Additional Manufacturer Narrative
Additional information: b5, g3, h2, h6.One bi-directional, curve d-f, sensor enabled, advisor hd grid x mapping catheter was received for evaluation.One image was also submitted to product performance engineering for evaluation.No thrombus was noted on the returned device; however, the image submitted with the returned device shows a thrombus on the paddle assembly.No resistance or functional anomalies were noted when the catheter was advanced through a sheath assembly from current inventory.In addition, the catheter met acceptable irrigation rates during a flow test with no anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the thrombus and reported withdrawal difficulty remains unknown.
Event or Problem Description
This report includes an updated analysis.

• Brand Name: ADVISOR¿ HD GRID X¿ MAPPING CATHETER, SENSOR ENABLED¿
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22862275
• Report Number: 3005334138-2025-00506
• Device Sequence Number: 15374968
• Product Code: MTD
• UDI-Device Identifier: 05415067049889
• UDI-Public: (01)05415067049889(10)10847779(17)260430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: D-AVHDX-DF16
• Device Catalogue Number: D-AVHDX-DF16
• Device Lot Number: 10847779
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/29/2025; 10/23/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/01/2025; 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2025
• 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: Male