MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT X3 CATHETER

Model Number	18-5000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device deficiency reported.Cardiac perforation and tamponade are known potential adverse events of catheter ablation procedures disclosed in product labeling.
Event or Problem Description
During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, it was initially believed the left superior pulmonary vein (lspv) had been accessed.However, the endoscopic image revealed trabeculations and the catheter tip appeared slightly bent on fluoroscopy, indicating possible entry into the left atrial appendage.The balloon was deflated and advanced into what appeared to be a notably large vein, later identified as a common vein.The balloon was deflated again and inserted into the initial structure.A drop in blood pressure was observed and preparation for pericardiocentesis was begun for suspected pericardial effusion.However, the patient's condition continued to worsen requiring multiple rounds of chest compressions.The patient was stabilized and surgery was performed to repair a small tear near the base of the left atrial appendage.The surgery went well, with discharge 3 days post-procedure.The cause of the perforation could not be definitively determined but most likely attributed to the ablation catheter.

• 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: 17961188
• Report Number: 1225698-2023-00020
• Device Sequence Number: 17401847
• Product Code: OAE
• UDI-Device Identifier: 00859373007433
• UDI-Public: 00859373007433
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/18/2023

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: 06/30/2024
• 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: 09/19/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• 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: Required Intervention; Other; Hospitalization; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Male