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	Pericardial Effusion (3271)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device deficiency was reported.Pericardial effusion is a known potential adverse event for catheter ablation procedures disclosed in product labeling.
Event or Problem Description
During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, a small pericardial effusion was noticed on intracardiac echocardiography (ice).Ice was used after the transseptal puncture but prior to ablation to check for effusion, with none found.The left superior pulmonary vein (lspv) was ablated with no issues.While moving from the lspv to the left inferior pulmonary vein (lipv) the tip of the balloon catheter was possibly inserted in the left atrial appendage.After accessing the lipv, the effusion was noted as well as a drop in blood pressure.Pericardiocentesis was performed, after which the effusion was noted to be stable.

• 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: 17845961
• Report Number: 1225698-2023-00018
• Device Sequence Number: 7381821
• Product Code: OAE
• UDI-Device Identifier: 00859373007433
• UDI-Public: 00859373007433
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/29/2023

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: 05/31/2024
• 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: 08/31/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 133 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White