MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT SHEATH

Model Number 18-3356

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 311916817
• Report Number: 1225698-2023-00007
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00868976000147
• UDI-Public: 00868976000147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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
• Patient Age: 50 YR
• Patient Sex: Male