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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no device deficiency reported, but the user did report a high number of energy deliveries because of difficulty in obtaining balloon/tissue contact.There was no increase in esophageal temperature, but the physician believes the large number of energy deliveries might have effected the esophageal, and gastric functions of the vagus nerve.Nerve injury is a known complication of catheter ablation procedures.
Event or Problem Description
A report was received of gastric dilation on x-ray following a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation.The patient was discharged but later began having symptoms of abdominal distension which were medically treated with successful resolution approximately four months post-onset.The treating physician believes the gastric dilation is probably related to the pvi procedure.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT CATHETER
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• MDR Report Key: 11027209
• Report Number: 1225698-2020-00035
• Device Sequence Number: 11632437
• 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): 12/17/2020

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 Model Number: 18-2531-N250
• Device Catalogue Number: 18-2531-N250
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/17/2020
• 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