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	08/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During insertion of the catheter to perform a pulmonary vein isolation (pvi) procedure, the catheter appeared to be inside the left atrial appendage instead of a pulmonary vein, which was confirmed by inflating the balloon.The catheter was removed and reinserted again into the left atrial appendage, confirmed by balloon inflation.The catheter was withdrawn and inserted into the left superior pulmonary vein.While ablation was started, blood pressure dropped and all catheters were removed.Pericardiocentesis was performed to drain excess fluid but surgery was needed to repair a perforation in the left atrial appendage.The patient was reported to be doing well post-procedure.
Additional Manufacturer Narrative
No device deficiency reported.Cardiac perforation and tamponade are known potential adverse events of catheter ablation procedures disclosed in product labeling.Cardiofocus received medwatch report mw5145264 from fda.While the initial reporter and device serial number was listed as not releasable, the event date and description in mw5145264 match the report received from a company representative, and the company is unaware of any other event matching the description documented in mw5145264.

• 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: 17817666
• Report Number: 1225698-2023-00016
• Device Sequence Number: 2342533
• 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): 09/26/2023

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: 03/31/2024
• 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: 08/28/2023
• Initial Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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: Other; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White