MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT CATHETER

Model Number 18-2531-N250

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Patient Problem/Medical Problem (2688)

Event Date 10/06/2018

Event Type  Injury  

Manufacturer Narrative

The procedure was completed with no problems on (b)(6) 2018.No device deficiency was reported.The adverse event was noticed on (b)(6) 2018.The incident was brought to cardiofocus notice on (b)(6) 2018.Pericarditis 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 Description

The ablation procedure was performed using the heartlight catheter on the (b)(6) 2018.All four pvs were successfully isolated and the procedure was completed with no problems.The patient complained of pain in his left chest the next day.This pain was aggravated while the patient was exhaling and his body temperature was 38 degrees centigrade.From the morphological changes on the ecg, the patient was diagnosed with pericarditis.

• Brand Name: HEARTLIGHT
• Type of Device: HEARTLIGHT CATHETER
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• Manufacturer Contact: ian christianson ; 500 nickerson rd suite 500-200; marlboro, MA 01752 ; 5086587231
• MDR Report Key: 8019548
• MDR Text Key: 125490415
• Report Number: 1225698-2018-00019
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00868976000109
• UDI-Public: 00868976000109
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P150026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/30/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 18-2531-N250
• Device Catalogue Number: 18-2531-N250
• Device Lot Number: 10652-029
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other