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	05/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device deficiency reported.Phrenic nerve damage is a known potential adverse event documented in product labeling.This patient is enrolled in the (b)(6) study ((b)(6)).
Event or Problem Description
Pvi procedure was performed (b)(6) 2019.During ablation of the rspv, transient loss of diaphragmatic stimulation was noted, but by the end of the case, phrenic nerve appeared to be intact based on sniff test.Sometime after the procedure the patient called the physician's office with complaints of shortness of breath, difficulty swallowing, and fleeting chest pain, and was advised to go to ed.In ed, chest x-ray revealed elevated right hemidiaphragm.Ed ruled out acute process and patient was discharged to home.Echo procedure was performed on (b)(6) 2019 and results were grossly within normal limits.Sniff test was performed on (b)(6) 2019 and revealed clear diaphragmatic paralysis.

• 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: 8745796
• Report Number: 1225698-2019-00015
• Device Sequence Number: 2371982
• Product Code: OAE
• UDI-Device Identifier: 00868976000178
• UDI-Public: 00868976000178
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/28/2019

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: 03/31/2020
• Device Model Number: 18-4000-27A
• Device Catalogue Number: 18-4000-27A
• Device Lot Number: 11171-013
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/28/2019
• 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: 68 YR
• Patient Weight: 68