MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR¿ HD GRID X¿ MAPPING CATHETER, SENSOR ENABLED¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D-AVHDX-DF16
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a premature ventricular contraction procedure, a communication issue occurred causing a procedure delay.The advisor hd grid x catheter was inserted into an agilis sheath and when an attempt was made to start mapping, the catheter did not connect to the ensitex system; the catheter showed red on the system and no signals were received.The entire ensite system was restarted and a new advisor hd grid x was obtained.The procedure was then completed with no patient consequences.
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.The sensors, eeprom and jumper met specifications for acceptable resistance values, and continuity was detected across the eeprom.No open or short circuits were detected.Additionally, the catheter was successfully connected to and recognized by an ensite x system.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported communication issue and subsequent delay remains unknown.
Additional Manufacturer Narrative
Correction: d2b.

• Brand Name: ADVISOR¿ HD GRID X¿ MAPPING CATHETER, SENSOR ENABLED¿
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE 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): ST. JUDE 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: 22046797
• Report Number: 3008452825-2025-00236
• Device Sequence Number: 8781673
• Product Code: MTD
• UDI-Device Identifier: 05415067049889
• UDI-Public: (01)05415067049889(10)10720079(17)260131
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 08/27/2025

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: 01/31/2026
• Device Model Number: D-AVHDX-DF16
• Device Catalogue Number: D-AVHDX-DF16
• Device Lot Number: 10720079
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 07/09/2025; 08/27/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/10/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown