MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT X3 CATHETER

Model Number 18-5000 (EU)

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/11/2022

Event Type  malfunction  

Manufacturer Narrative

The returned catheter shows damage to the distal end of the lesion generator.This damage is consistent with the report of extreme clinical use in accessing and treating a small branch of the ripv.The damage allowed fluid into the lesion generator component and resulted in energy being directed to the distal tip of the catheter, resulting in melting and ultimately dislodgement of the catheter tip distal to the balloon.This event required two different faults to occur.The first fault was the damage to the distal end of the lesion generator.The second fault was clinical use in that the aiming beam appearance was noted to be unusual but energy delivery was continued.Because the user can always see where the laser energy is being directed on the real-time, direct visualization feature of the system, and the instructions for use (ifu) for the catheter and console and customer training materials state to not deliver energy when the visible aiming beam of laser energy decreases in intensity or appears abnormal, delivering energy with no visible aiming beam is contrary to the ifu.In this event, one of the treating physicians stated the aiming beam appeared split while delivering energy in the ripv.While not a direct mitigation, the tip of the catheter contains a radiopacifier and two platinum-iridium marker spheres.Thus, the tip is easily visualized on fluoroscopy and in this case the tip was retrieved with a snare with no complication to the patient.

Event Description

During a pulmonary vein isolation procedure to treat atrial fibrilaltion, two pulmonary veins were successfully ablated with no complications reported.The third vein to be ablated was the right inferior pulmonary vein (ripv), and the catheter was first placed in a small branch of the ripv.The end of the catheter was deflected because of the small vein and the ablation was performed very distal in the catheter during which time an irregular appearance of the aiming beam was noted.However, ablation was continued.When the catheter was removed, the distal tip was missing.The distal tip was safely removed with a snare.There was no patient complication reported.

• Brand Name: HEARTLIGHT
• Type of Device: HEARTLIGHT X3 CATHETER
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; marlboro MA 01752
• Manufacturer Contact: ian christianson ; 500 nickerson rd.; marlboro, MA 01752
• MDR Report Key: 15195305
• MDR Text Key: 304709701
• Report Number: 1225698-2022-00018
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: P150026
• 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
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 18-5000 (EU)
• Device Catalogue Number: 18-5000 (EU)
• Device Lot Number: 16926-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• 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
• Patient Outcome(s): Required Intervention