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 Code	Transient Ischemic Attack (2109)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: HEARTLIGHT CATHETER WITH EXCALIBUR BALLOON
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• MDR Report Key: 9434432
• Report Number: 1225698-2019-00038
• Device Sequence Number: 2230373
• Product Code: OAE
• UDI-Device Identifier: 00868976000178
• UDI-Public: 00868976000178
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 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
• Operator of Device: Health Professional
• Device Model Number: 18-4000-27A
• Device Catalogue Number: 18-4000-27A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/06/2019
• 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: Other