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

Model Number 18-4000-27A

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

Patient Problem Transient Ischemic Attack (2109)

Event Type  Injury  

Manufacturer Narrative

This adverse event was one of three reported in an advance publication and was not reported directly to the manufacturer.A request for additional information has been made.The response from the treating physician was the source of the complication was unknown yet most likely not directly related to the manufacturer's device.However, since the cause of the adverse event cannot be determined, this event is being reported.If additional information is received a supplemental report will be issued.The publication is circulation journal, doi: 10.1253/circj.Cj-19-0766.Transient ischemic attack is a known potential adverse event for catheter ablation procedures.

Event Description

An advance literature publication reported a periprocedural transient ischemic attack of unknown source during a pulmonary vein isolation (pvi) procedure.The symptoms completely resolved during the hospital stay.No product information was provided and no device deficiency reported.

• Brand Name: HEARTLIGHT
• Type of Device: HEARTLIGHT CATHETER WITH EXCALIBUR BALLOON
• 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: 9434432
• MDR Text Key: 170006435
• Report Number: 1225698-2019-00038
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00868976000178
• UDI-Public: 00868976000178
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2019

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
• Device Operator: Health Professional
• Device Model Number: 18-4000-27A
• Device Catalogue Number: 18-4000-27A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other