MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT DEFLECTABLE SHEATH

Model Number 18-3356

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Type  Injury  

Manufacturer Narrative

No device deficiency reported.Procedure date and device lot number requested but could not be obtained.Relationship between device and report of st segment elevation suspected to be the result of air embolism cannot be determined.Air embolism is a known potential adverse event for catheter ablation procedures disclosed in product labeling.

Event Description

During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, transient st segment elevation was noted.The treating physician attributed the st segment elevation to air entry through the deflectable sheath.An unknown medication was administered, the st segment elevation resolved, and the pvi procedure was completed.The patient was discharged without any symptoms or sequelae.

• Brand Name: HEARTLIGHT
• Type of Device: HEARTLIGHT DEFLECTABLE SHEATH
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• Manufacturer Contact: ian christianson ; 500 nickerson rd.; suite 500-200; marlboro, MA 01752 ; 5086587231
• MDR Report Key: 11026943
• MDR Text Key: 222015044
• Report Number: 1225698-2020-00034
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00868976000147
• UDI-Public: 00868976000147
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 18-3356
• Device Catalogue Number: 18-3356
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other