MAUDE Adverse Event Report: Abbott Medical Advisor¿ HD Grid Mapping Catheter, Sensor Enabled¿; Catheter, Electrode Recording, Or Probe, Electrode Recording

Model Number	D-AVHD-DF16
Medical Device Problem Codes	Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a premature ventricular contraction procedure, leakage was observed from the intravenous line connected to the advisor hd grid mapping catheter and the flow of irrigation was obstructed.The physician suspected the presence of a blood clot after performing troubleshooting measures; however, this could not be definitively confirmed.The catheter was irrigated via gravity.The catheter was exchanged, and the procedure was completed with no adverse consequences to the patient.Based on the reported event information, the advisor hd grid catheter was irrigated via gravity, which does not align with the instructions for use (ifu).

• Brand Name: Advisor¿ HD Grid Mapping Catheter, Sensor Enabled¿
• Common Device Name: Catheter, Electrode Recording, Or Probe, Electrode Recording
• 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 ; +1(651)756-5400
• MDR Report Key: 50459728
• Report Number: 3008452825-2026-00451
• Device Sequence Number: 10241525
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: (01)05415067028198(10)10835641(17)280331
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K202066
• 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
• Report Date (Section B): 08/26/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: D-AVHD-DF16
• Device Catalogue Number: D-AVHD-DF16
• Device Lot Number: 10835641
• 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: 08/11/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2025
• 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: Unknown