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	Air Embolism (1697)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device deficiency reported.Relationship between device and adverse event cannot be determined.Air embolism 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, sheath exchange was performed and the dilator for the ablation catheter introducer sheath was removed from the sheath.Shortly after the sheath exchange a drop in blood pressure and st segment elevation on ecg were noted.Air bubbles were visually confirmed in the aortic arch and right coronary artery, confirming air embolism.Attempts to aspirate the air bubbles were not successful.Blood pressure recovered after about 15-20 minutes and the procedure was stopped.Post-procedural ct scan showed no evidence of injury.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT DEFLECTABLE SHEATH
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro, ma
• MDR Report Key: 9772094
• Report Number: 1225698-2020-00006
• Device Sequence Number: 2574607
• Product Code: DRA
• UDI-Device Identifier: 00868976000147
• UDI-Public: 00868976000147
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: 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: 02/04/2020
• Initial Report FDA Received Date: 02/28/2020
• 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: 70 YR