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 Codes	Nerve Damage (1979); Patient Problem/Medical Problem (2688)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device deficiency reported.Phrenic nerve injury leading to diaphragmatic paralysis is a known potential adverse event for catheter ablation procedures disclosed in product labeling.
Event or Problem Description
A pulmonary vein isolation (pvi) procedure was performed on (b)(6) 2020 without incident.High output pacing of the phrenic nerve was performed and there was no loss of capture during the procedure.The patient was admitted to the hospital on (b)(6) 2020 with decreased lung volume and released on (b)(6) 2020 with improved lung volume.The treating physician concluded the decreased lung volume was most likely due to a phrenic nerve injury, despite there being no presentation of injury during the procedure.The patient is expected to make a full recovery.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT CATHETER WITH EXCALIBUR BALLOON
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro, ma
• MDR Report Key: 9793614
• Report Number: 1225698-2020-00007
• Device Sequence Number: 2411459
• Product Code: OAE
• UDI-Device Identifier: 00868976000178
• UDI-Public: 00868976000178
• Combination Product (Y/N): N
• 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): 03/05/2020

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: 11/30/2020
• Device Model Number: 18-4000-27A
• Device Catalogue Number: 18-4000-27A
• Device Lot Number: 11963-036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/05/2020
• 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: Hospitalization; Other
• Patient Age: 66 YR