MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT X3 CATHETER

Model Number	18-5000
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1225698-2023-00008
• Device Sequence Number: 15294351
• Product Code: OAE
• UDI-Device Identifier: 00859373007433
• UDI-Public: 00859373007433
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P150026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American