MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT CATHETER

Model Number	18-2531-N250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device deficiency reported.Phrenic nerve injury leading to diaphragmmatic paralysis is a known potential adverse event for catheter ablation procedures disclosed in product labeling.
Event or Problem Description
During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, reduction in the diaphragmatic response was confirmed by palpation and compound muscle activation potential (cmap) amplitude while ablating the right superior pulmonary vein (rspv).This reduction in motion of the diaphragm was confirmed with fluoroscopy.Subsequently it was reported that significant improvement but not full resolution of the diapgragmatic movement had been observed and the patient had been released without prolongation of hospitalization.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT CATHETER
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• MDR Report Key: 10787948
• Report Number: 1225698-2020-00031
• Device Sequence Number: 3644508
• Product Code: OAE
• UDI-Device Identifier: 00868976000109
• UDI-Public: 00868976000109
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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: 03/31/2021
• Device Model Number: 18-2531-N250
• Device Catalogue Number: 18-2531-N250
• Device Lot Number: 12388-003
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/04/2020
• 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: Other
• Patient Age: 58 YR