MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT CATHETER WITH EXCALIBUR BALLOON

Model Number	18-4000-27A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Perforation of Esophagus (2399)
Date of Event	03/13/2019
Type of Reportable Event	Death
Event or Problem Description
Patient was treated with heartlight system on (b)(6) 2019.Patient had a left common pulmonary vein (lcpv).Esophageal temperature rises were experienced when ablating along the posterior wall of the lcpv.Numerous locations along the posterior wall were ablated where temperature rises were observed.Ablation was discontinued when observed esophagus temperature exceeded 38.5° c, resulting in short energy deliveries.The lcpv was not isolated.The heartlight catheter was removed and the posterior wall of the same vein was treated with 2-3 full freezes using cryocath.On (b)(6) 2019 the patient reported fever and neurological symptoms.Atrio-esophageal fistula was confirmed, which led to patient death.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT CATHETER WITH EXCALIBUR BALLOON
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd suite 500-200; marlboro MA 01752
• MDR Report Key: 8495760
• Report Number: 1225698-2019-00008
• Device Sequence Number: 1253697
• Product Code: OAE
• UDI-Device Identifier: 00868976000178
• UDI-Public: 00868976000178
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2019

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: 05/31/2019
• Device Model Number: 18-4000-27A
• Device Catalogue Number: 18-4000-27A
• Device Lot Number: 10416-08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/09/2019
• 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: Death
• Patient Age: 62 YR
• Patient Weight: 95