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	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
After a successful pulmonary vein isolation (pvi) procedure to treat atrial fibrillation on (b)(6) 2023, the patient woke up without full movement in the left arm/hand.A minor stroke was diagnosed.The patient was discharged the day following the procedure.Follow-up information was received on august 29, 2023 where the patient was reported as doing very well, although with residual effects from the adverse event.Full recovery is expected after physical therapy.No device deficiency was reported with any ablation system devices.The treating physician was unable to determine if there was a relationship between the adverse event and the ablation system devices.Because the cause of the stroke cannot be conclusively determined, this event is being reported.
Additional Manufacturer Narrative
No device deficiency reported and relationship between device, procedure, and adverse event cannot be determined.Stroke is a known possible event disclosed in product labeling.Tubing unrelated to the ablation system broke prior to the transseptal puncture, allowing blood to leak and requiring replacement.The act prior to transseptal puncture was abnormally low but was brought up to therapeutic level.Finally, a small amount of char was observed on the carina of the right inferior pulmonary vein due to ablation of an area of thinner tissue in the right superior pulmonary vein.It is unknown if any of these issues had any relationship to the adverse event.

• 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: 17735983
• Report Number: 1225698-2023-00014
• Device Sequence Number: 6576452
• 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): 09/13/2023

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: 11/30/2023
• 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: 08/16/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native, Black Or African American