MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT SHEATH

Model Number 18-3356

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 01/27/2022

Event Type  Injury  

Event Description

During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, blood pressure became unstable while ablating the right inferior pulmonary vein after ablation of the left-sided veins.Order of vein treatment was left superior, left inferior, right inferior, and right superior.After ablation of the right superior pulmonary vein it was determined cardiac tamponade had occurred.Cardiac drainage was immediately performed but additional treatment was required including surgical repair.The perforation site was identified as the tip of the left atrial appendage.Approximately one week post procedure the patient was showing signs of improvement.

Manufacturer Narrative

No device deficiency reported.Cardiac tamponade is a known potential adverse event of catheter ablation procedures disclosed in product labeling.It was reported the tip of the ablation catheter was completely inside the sheath while the sheath was manipulated in the left atrium.This is contrary to product labeling in which the soft tip of the catheter is recommended to be extended from the sheath during sheath movement.It cannot be determined if this deviation from the instructions from use contributed to this adverse event.The cause of the perforation was not determined, but the sheath cannot be excluded as a cause.

Manufacturer Narrative

No device deficiency reported.Cardiac tamponade is a known potential adverse event of catheter ablation procedures disclosed in product labeling.It was reported the tip of the ablation catheter was completely inside the sheath while the sheath was manipulated in the left atrium.This is contrary to product labeling in which the soft tip of the catheter is recommended to be extended from the sheath during sheath movement.It cannot be determined if this deviation from the instructions from use contributed to this adverse event.The cause of the perforation was not determined, but the sheath cannot be excluded as a cause.

Event Description

During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, blood pressure became unstable while ablating the right inferior pulmonary vein after ablation of the left-sided veins.Order of vein treatment was left superior, left inferior, right inferior, and right superior.After ablation of the right superior pulmonary vein it was determined cardiac tamponade had occurred.Cardiac drainage was immediately performed but additional treatment was required including surgical repair.The perforation site was identified as the tip of the left atrial appendage.Approximately one week post procedure the patient was showing signs of improvement.

• Brand Name: HEARTLIGHT
• Type of Device: HEARTLIGHT 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: 13560982
• MDR Text Key: 286070014
• Report Number: 1225698-2022-00003
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2023
• Device Model Number: 18-3356
• Device Catalogue Number: 18-3356
• Device Lot Number: E2044246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male