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 11/09/2021

Event Type  malfunction  

Event Description

During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, two pulmonary veins were successfully ablated.During ablation of the third vein, the appearance of the aiming beam in the endoscopic image was noticed to have diminished.Ablation continued until the aiming beam was obseved to almost disappear.The catheter was removed for replacement at which point the catheter tip was observed to be missing.The tip was safely removed with a snare.There was no patient complication reported.The instructions for use direct user to discontinue use of catheter if the aiming beam intensity is reduced.

Manufacturer Narrative

Investigation is still in process.A follow-up mdr will be submitted with investigation conclusions.

Manufacturer Narrative

The root cause of this event was likely laser 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 is due to clinical use.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) 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, the snapshot images saved on the system console show the final energy deliveries with no visible aiming beam.The second fault is damage to the part of the catheter that delivers energy, which is called the lesion generator.Damage to the lesion generator can occur due to extreme clinical use during the procedure or from a latent manufacturing defect.In this event, evaluation of the returned device determines it is likely there was a latent defect in this catheter.The manufacturing defect was latent because there is 100% inspection and testing of lesion generators in manufacturing.While not a direct mitigation, the tip of the catheter contains a radio-pacifier and two platinum-iridium marker spheres.Thus, the tip is easily visualized on fluoroscopy and in this case was relatively easy to snare and retrieve without complication to the patient.

Event Description

During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, two pulmonary veins were successfully ablated.During ablation of the third vein, the appearance of the aiming beam in the endoscopic image was noticed to have diminished.Ablation continued until the aiming beam was obseved to almost disappear.The catheter was removed for replacement at which point the catheter tip was observed to be missing.The tip was safely removed with a snare.There was no patient complication reported.The instructions for use direct user to discontinue use of catheter if the aiming beam intensity is reduced.

• Brand Name: HEARTLIGHT
• Type of Device: HEARTLIGHT X3 CATHETER
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• Manufacturer Contact: ian christianson ; 500 nickerson rd.; suite 500-200; marlboro, MA 01752 ; 5086587231
• MDR Report Key: 12963284
• MDR Text Key: 289902627
• Report Number: 1225698-2021-00030
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 18-5000 (EU)
• Device Catalogue Number: 18-5000 (EU)
• Device Lot Number: 15230-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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