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

Model Number	18-4000-27A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Laceration(s) of Esophagus (2398); Patient Problem/Medical Problem (2688)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The procedure was completed with no problems on (b)(6) 2018 as part of the (b)(6) study bundled under p150026 and p150026/s002, protocol no.(b)(6).No device deficiency was reported.The adverse event was first reported by the patient on (b)(6) 2018.Cardiofocus was made aware of the adverse event on 7-nov-2018 by the study site.Esophageal ulceration is a known adverse event associated with any cardiac ablation procedure.There is no additional information for this adverse event.If any information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Ablation was done on (b)(6) 2018 and on (b)(6) 2018 the patient returned with chest pain.Patient was diagnosed with esophageal ulcer and was treated medically and discharged on (b)(6) 2018.Patient was back to baseline at follow-up visit on (b)(6) 2018.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT EXCALIBUR BALLOON CATHETER
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• MDR Report Key: 8103541
• Report Number: 1225698-2018-00021
• Device Sequence Number: 1598966
• Product Code: OAE
• UDI-Device Identifier: 00868976000178
• UDI-Public: 00868976000178
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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: 09/30/2019
• Device Model Number: 18-4000-27A
• Device Catalogue Number: 18-4000-27A
• Device Lot Number: 10697-006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 11/26/2018
• 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: Hospitalization; Other
• Patient Age: 56 YR
• Patient Weight: 81