MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT X3 CATHETER

Model Number 18-5000 (JP)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nerve Damage (1979)

Event Date 11/10/2023

Event Type  Injury  

Manufacturer Narrative

No produce deficiency reported.Phrenic nerve injury is a known potential adverse event for catheter ablation procedures disclosed in product labeling.

Event Description

During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, the phrenic nerve could not be captured while ablating the right superior pulmonary vein (rspv), the procedure was completed and the patient was discharged.An update was received two weeks post-procedure that while the phrenic nerve injury had not fully recovered, the phrenic nerve function was within an acceptable range.Since a phrenic nerve injury persisting beyond discharge occurred, this event is being 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 ; 5086587231
• MDR Report Key: 18280066
• MDR Text Key: 329888267
• Report Number: 1225698-2023-00021
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 18-5000 (JP)
• Device Catalogue Number: 18-5000 (JP)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male