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	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, after transseptal puncture, an echogenic string-like material was seen on the tip of the catheter in the left atrium via ice.This was noted directly after advancing the catheter through the sheath and prior to any mapping.At first it was assumed to be a clot coming from the tip of the grid, however the act was well above the suggested 300 seconds.The catheter was carefully removed from the patient while aspirating the sheath.It was confirmed nothing was left within the left atrium via ice.After closer inspection of the catheter tip outside the patient, it was confirmed not to be a clot but stray thin wiring tangled around the top coupling joint of the catheter.It was wrapped around several times.The wiring was as thin as a strand of hair and difficult to see to the naked eye.The catheter was replaced, and the procedure was successful completed with no adverse events.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.One image was submitted for evaluation to product performance engineering; no product was received.The image returned shows a thin string-like material on a surface with liquid.The string-like material was not easily distinguishable.The device history 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 an "an echogenic string-like material was seen on the tip of the catheter" could not be conclusively determined.

• 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: 23831941
• Report Number: 3008452825-2025-00656
• Device Sequence Number: 9030668
• Product Code: MTD
• UDI-Device Identifier: 05415067049889
• UDI-Public: (01)05415067049889(10)11037851(17)280831
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/10/2026

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
• Device Lot Number: 11037851
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2025
• 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: 77 YR
• Patient Sex: Female