MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT CATHETER WITH EXCALIBUR BALLOON, PRODUCT CODE: OAE

Model Number	18-4000-27A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Infarction, Cerebral (1771)
Date of Event	04/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was persistent atrial fibrillation with biv icd.Treatment was performed under general anesthesia.Carto was used with ice.Transseptal puncture performed with manufacturer sheath and amplatz wire - manufacturer representatives advised treating physicians multiple times that sheath was not designed for primary transseptal.No issues reported with transseptal puncture.Pentaray catheter used to collect geometry, voltage levels, and pv activity.Act's maintained at 300 or above.Post af ablation a cavo tricuspid flutter ablation performed with another manufacturer's catheter.No deficiencies were reported with any device.
Event or Problem Description
Patient was treated with heartlight system on (b)(6) 2019.Manufacturer representative was informed day after ablation procedure (april 12, 2019) that the patient had a stroke, severity unknown.No device deficiencies reported and physicians involved expressed doubt heartlight system was cause of stroke.However, relationship between the stroke and adverse event cannot be excluded.In addition to stroke, the manufacturer representative was informed patient was having groin issues post-procedure, severity unknown.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT CATHETER WITH EXCALIBUR BALLOON, PRODUCT CODE: OAE
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• MDR Report Key: 8594918
• Report Number: 1225698-2019-00009
• Device Sequence Number: 16662626
• Product Code: OAE
• UDI-Device Identifier: 00868976000178
• UDI-Public: 00868976000178
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 05/08/2019

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: 10/31/2019
• Device Model Number: 18-4000-27A
• Device Catalogue Number: 18-4000-27A
• Device Lot Number: 10779-007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAVO TRICUSPID FLUTTER W/ ANOTHER COMPANY DEVICE
• Outcome Attributed to Adverse Event: Other