MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT X3 CATHETER

Model Number 18-5000

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 03/08/2023

Event Type  Injury  

Manufacturer Narrative

No device deficiency reported.Stroke is a known potenital adverse event for any catheter ablation procedure disclosed in product labeling.It was reported energy may have been delivered over a small vessel in a pulmonary vein, with subsequent char formation which may have caused or contributed to the adverse event.The location of energy delivery is visible to the user in the endosocpic image and the location of energy delivery can be easily adjusted.

Event Description

During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation it was noted that energy may have been delivered over a small vessel in a pulmonary vein.When the catheter's balloon was removed it was noted that some char was stuck to the balloon.Five days post-procedure the treating physician notified the company the patient had woken with a slight facial droop, which was confirmed to be a stroke.The patient was reported to be doing well approximately 2 weeks post-procedure.

• 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: 16721383
• MDR Text Key: 313106647
• Report Number: 1225698-2023-00008
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00859373007433
• UDI-Public: 00859373007433
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2023

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: 11/30/2023
• Device Model Number: 18-5000
• Device Catalogue Number: 18-5000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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): Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American