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 Improper or Incorrect Procedure or Method (2017); Device Contamination with Body Fluid (2317); Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/14/2024

Event Type  malfunction  

Event Description

During a premature ventricular contraction ablation procedure, a thrombus was suspected on the mapping catheter.The catheter was inserted into the right atria before the central lumen irrigation was connected.It remained in the atria for approximately 5 mins.It was removed from the atria to allow connection of the central lumen irrigation fluid.Upon withdrawal it was noted that it was not possible to irrigate the catheter.It was suspected that ted that thrombus had formed within the central lumen but the physician raised the possible that there may have been a manufacturing defect.No clot or thrombus was confirmed.The catheter was replaced and the procedure was completed without further issue.

Manufacturer Narrative

One bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.The fluid lumen was found to be occluded with blood-like substance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Information received indicates the catheter was inserted to the patient prior to the device being connected and testing for irrigation.Advisor¿ hd grid mapping catheter, sensor enabled instructions for use (ifu) states, ¿maintain constant irrigation to prevent coagulation on the distal paddle¿ the cause of the reported event is consistent with not following the instructions for use.

• 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: 18950528
• MDR Text Key: 338611425
• Report Number: 3008452825-2024-00148
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: 05415067028198
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K172393, K20
• 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: 04/23/2024

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
• Device Operator: Health Professional
• Device Model Number: D-AVHD-DF16
• Device Lot Number: 10112118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2023
• 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