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

Model Number D-AVHD-DF16

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2023

Event Type  malfunction  

Event Description

Related manufacturing reference: 3008452825-2024-00029, 3008452825-2024-00030, 3008452825-2024-00031.During the atrial fibrillation procedure, communication issues required multiple troubleshooting measures and resulted in a procedural delay.The devices were all exchanged and the procedure was completed with no adverse consequences to the patient.The patches were applied to the patient, the ablation catheter and the mapping catheter were inserted into the heart, mapping was performed, rf delivery was started and the right pulmonary vein isolation was started.When the right pulmonary vein isolation was performed to the middle, it was noted that the electrodes 2-4 of the ablation catheter were displayed in red and the navigation became unable to be displayed.The direct connect cable for ablation catheter extension was exchanged with no resolution.The ablation catheter was replaced with no resolution.The ensite was restarted and resume study was performed, but the same issue occurred with both the catheters.The issue was resolved after registering as a new patient and replacing the patches, replacing the ablation catheter, and replacing the mapping catheter at the same time.The procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

Additional information: d9, g3, h2, h3, h6 one bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.Electrodes 17-18 and the sensors met specifications for acceptable resistance values with no open or short circuits 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 remains unknown.

• Brand Name: ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿
• Type of Device: 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18518322
• MDR Text Key: 332988592
• Report Number: 3008452825-2024-00032
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: 05415067028198
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-AVHD-DF16
• Device Lot Number: 9108264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENSITE¿ X EP SYSTEM SURFACE ELECTRODE KIT (1PK JP).; TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿.; TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿.