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 Code	Cardiac Tamponade (2226)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device deficiency reported.Cardiac tamponade is a known potential adverse event of catheter ablation procedures disclosed in product labeling.
Event or Problem Description
During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, blood pressure dropped while attempting to position the catheter in the right inferior pulmonary vein (ripv).Intracardiac echocardiography (ice) revealed pericardial effusion with evidence of cardiac tamponade.The ablation devices were withdrawn, heparin reversed, and a pericardial tap was performed.The patient improved with conservative measures and surgery was not required.The cause of the cardiac tamponade cannot be definitively determined but the event report indicates involvement of 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
• MDR Report Key: 16603838
• Report Number: 1225698-2023-00006
• Device Sequence Number: 17973079
• Product Code: OAE
• UDI-Device Identifier: 00859373007433
• UDI-Public: 00859373007433
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2023

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: 09/30/2023
• Device Model Number: 18-5000
• Device Catalogue Number: 18-5000
• Device Lot Number: 18862-001
• 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: 02/24/2023
• Initial Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White