MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT CATHETER

Model Number	18-2531-N250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device deficiency reported.Pulmonary vein stenosis is a known possible complication of catheter ablation for atrial fibrillation procedures documented in product labeling.This event was not reported at the time of occurrence.
Event or Problem Description
A report was received of pulmonary vein (pv) stenosis after a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation.Stenosis of the right superior pulmonary vein (rspv) of 80% to 90% was reported.The exact procedure date was not reported but was prior to (b)(6) 2020.Treatment by dilating the pv with a balloon was reported to be planned but no additional information on patient status could be obtained.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT 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: 14250050
• Report Number: 1225698-2022-00009
• Device Sequence Number: 14645875
• Product Code: OAE
• UDI-Device Identifier: 00868976000109
• UDI-Public: 00868976000109
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2022

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 Model Number: 18-2531-N250
• Device Catalogue Number: 18-2531-N250
• 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: 03/30/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown