MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT SHEATH

Model Number	18-3356
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1225698-2022-00003
• Device Sequence Number: 14527862
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2022

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male