MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT SHEATH

Model Number	18-3356
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device deficiency reported and it cannot be determined if there is any relationship between the deflectable sheath and the air entry.Air embolism is a known potential adverse event of catheter ablation procedures disclosed in product labeling.
Event or Problem Description
During a pulmonary vein isolation (pvi) procedure to treat atrial fibrilation, air bubbles were noted in the left atrium by intracardiac echocardiography (ice) after the ablation catheter had been replaced with a lasso catheter through the same deflectable sheath.An angiogram was performed and the air was manually aspirated out of the left atrium.No effect on the patient was reported.While no injury occurred and no device deficiency was reported, the removal of the air by the treating physician may have prevented an injury from occurring and this mdr is being reported as other serious or important medical events.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT SHEATH
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; marlboro MA 01752
• Manufacturer Contact: ian christianson ; 500 nickerson rd.; marlboro, MA 01752
• MDR Report Key: 16603157
• Report Number: 1225698-2023-00007
• Device Sequence Number: 20374745
• Product Code: DRA
• UDI-Device Identifier: 00868976000147
• UDI-Public: 00868976000147
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2023

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: 02/29/2024
• Device Model Number: 18-3356
• Device Catalogue Number: 18-3356
• Device Lot Number: E2357175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Male