MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT DEFLECTABLE SHEATH

Model Number	18-3356
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Infarction, Cerebral (1771)
Date of Event	07/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device deficiencies were reported.Stroke and air embolism are known potential adverse events documented in product labeling.The cause of the air embolism is unknown.The following additional devices were used and treatments were performed in addition to the pvi procedure.A mullins sheath and baylis nrg needle were used to gain transseptal access.After inserting a long wire, the mullins sheath was exchanged for the heartlight sheath.The biosense smarttouch catheter was placed through the heartlight sheath to create a matrix for the carto system.The smarttouch catheter was exchanged for a pentaray catheter to collect a pre-ablation voltage map.The pentaray was placed into the superior branch of the left common vein and exchanged for the heartlight excalibur balloon.Ablation was performed in the left common, right superior and right inferior.The excalibur balloon was exchanged for the pentaray.The post-ablation voltage map showed the right veins were isolated and a gap in the left common.The pentaray was exchanged for the excalibur balloon and the left common was re-ablated.The excalibur balloon was exchanged for the pentaray.The veins were rechecked and all found to be isolated.The heartlight sheath was moved into the right atrium atrium where the pentaray was exchanged for the smarttouch cathter.A cavotricuspid isthmus line was ablated and the heartlight sheath along with the ablation catheter were removed from the body.All heartlight products were prepared in normal fashion, to include deflating the excalibur balloon under water both as part of initial catheter preparation and prior to inserting to the catheter to re-ablate the left common.Cardiofocus has submitted mdr 1225698201900024 for the heartlight catheter used in this procedure.The relationship of the catheter to the air embolism is unknown, but cannot be excluded.
Event or Problem Description
Patient diagnosed with minor cerebral air embolism day after a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation.The pvi procedure was performed in normal fashion.Patient was to be discharged from the hospital when patient reported having blurred/double vision.An mri was performed and neurologist diagnosed minor cerebral air embolism.The patient's discharge was delayed one day.The patient's vision had returned to normal prior to discharge from the hospital.The cause of the air embolism could not be determined but the heartlight sheath cannot be excluded.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT DEFLECTABLE SHEATH
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• MDR Report Key: 8897345
• Report Number: 1225698-2019-00025
• Device Sequence Number: 10867547
• Product Code: DRA
• UDI-Device Identifier: 00868976000147
• UDI-Public: 00868976000147
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152310
• 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): 08/15/2019

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: 12/31/2020
• Device Model Number: 18-3356
• Device Catalogue Number: 18-3356
• Device Lot Number: Q1388071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/15/2019
• 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
• Patient Age: 65 YR