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	Stroke/CVA (1770)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, cardiac tamponade was noticed due to drop in blood pressure and confirmed using intracardiac echocardiography (ice).Anticoagulation was reversed using protamine and pericardiocentesis was performed.The treating physician assessed the relationship between the ablation system devices and the tamponade to be unlikely, with the likely cause of the tamponade being one of the other catheters (possibly the coronary sinus catheter) used in the procedure.The procedure was stopped and the patient extubated.The extubation exam noted no left arm movement which was diagnosed as a likely stroke.A computed tomography (ct) head scan did not show a bleed.The relationship between the ablation system devices and the stroke cannot be conclusively determined, but was deemed possible by the treating physician.
Additional Manufacturer Narrative
No device deficiency was reported.Stroke is a known possible adverse event disclosed in product labeling.Only the stroke is being coded in section h6 of this mdr as the tamponade was deemed unlikely to be related to the ablation device system by the treating physician.

• 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: 17795889
• Report Number: 1225698-2023-00015
• Device Sequence Number: 14000553
• Product Code: OAE
• UDI-Device Identifier: 00859373007433
• UDI-Public: 00859373007433
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/21/2023

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: 08/24/2023
• Initial Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• 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; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White