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	Infarction, Cerebral (1771)
Date of Event	04/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device deficiency reported.Cerebral infarction is a known potential adverse event for catheter ablation procedures disclosed in product labeling.This mdr is being reported because while there was no reported involvement of any component of the heartlight system in this event, it cannot be conclusively ruled out.
Event or Problem Description
Hours after the completion of an uneventful pulmonary vein isolation (pvi) procedure to treat atrial fibrillation the patient exhibited symptoms of a cerebral infarction and was transferred to a different hospital for treatment.The patient was reported to have recovered at the time the hospital notified the manufacturer's representative of this event.The cause of the cerebral infarction is unknown and it cannot be determined if there is any relationship with the ablation system.No other details are available for this event.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT CATHETER
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro, ma
• MDR Report Key: 10059047
• Report Number: 1225698-2020-00016
• Device Sequence Number: 11478382
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

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: 02/28/2021
• Device Model Number: 18-2531-N250
• Device Catalogue Number: 18-2531-N250
• Device Lot Number: 12192-003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR