MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT X3

Model Number 18-5000 (JP)

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/28/2022

Event Type  malfunction  

Manufacturer Narrative

The returned catheter showed damage to the distal end.The damage is consistent with the reported difficulty in preparation.The damage ultimately led to dislodgement of the catheter tip.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 fibrillation, the distal tip of the catheter was found to have detached while treating the left superior pulmonary vein.The tip was retrieved with a snare, the catheter was replaced, and the procedure was completed.Difficulty in device preparation was reported, which led to increased handling and likely damage of the catheter before use.

• Brand Name: HEARTLIGHT
• Type of Device: HEARTLIGHT X3
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; marlboro MA 01752
• Manufacturer Contact: ian christianson ; 500 nickerson rd.; marlboro, MA 01752
• MDR Report Key: 15824858
• MDR Text Key: 307508685
• Report Number: 1225698-2022-00022
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 18-5000 (JP)
• Device Catalogue Number: 18-5000 (JP)
• Device Lot Number: 17991-003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2022
• 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