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 Problems Communication or Transmission Problem (2896); Material Twisted/Bent (2981)

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

Event Date 01/19/2024

Event Type  malfunction  

Event Description

Related manufacturing reference: 3008452825-2024-00055.During an atrial fibrillation procedure, communication and display issues with the mapping catheters resulted in a procedural delay.The mapping catheter was inserted into the patient and plugged into the amplifier but it did not populate on the ensite x system.The cable was replaced but this did not resolve the issue.The cable and catheter were inspected and a bent pin was observed on the catheter.The catheter was exchanged and the second catheter was inserted into the patient but once plugged in it was noted that one of the electrodes was not displaying on ensite and did not allow for obtaining voxel cloud or for using the sheath filter.The cable was exchanged but the issue persisted.An hour of troubleshooting was performed changing cables and replacing ensite x hardware components but the issue was not resolved.The mapping catheter was replaced again which resolved the issue and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

Corrected data: b5, g3, h6 additional information: d9, g3, h2, h3, h6 one bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.Pins 41-43 were bent in the connector plug, which prevented the catheter from connecting to the cable to be electrically tested.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

Event Description

During an atrial fibrillation procedure, noise issues with the mapping catheters resulted in a procedural delay.The mapping catheter was inserted into the patient and plugged into the amplifier but it did not populate on the ensite x system.The cable was replaced but this did not resolve the issue.The cable and catheter were inspected and a bent pin was observed on the catheter.The catheter was exchanged and the second catheter was inserted into the patient but once plugged in it was noted that one of the electrodes was not displaying on ensite and did not allow for obtaining voxel cloud or for using the sheath filter.The cable was exchanged but the issue persisted.An hour of troubleshooting was performed changing cables and replacing ensite x hardware components but the issue was not resolved.The mapping catheter was replaced again which resolved the issue and the procedure was completed with no adverse consequences to the patient.

• 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: 18581693
• MDR Text Key: 333907204
• Report Number: 3008452825-2024-00054
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: 05415067028198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172393, K20
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• 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: 9182364
• 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: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2023
• 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: ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿