MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT DEFLECTABLE 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 09/13/2021

Event Type  Injury  

Manufacturer Narrative

No device deficiency was reported.Cardiac tamponade is a known potential adverse event of catheter ablation procedures disclosed in product labeling.The blood pressure drop was noted coincident with the positioning of another manufacturer's mapping catheter and sheath in the right superior pulmonary vein.The deflectable sheath was then moved to the left inferior pulmonary vein and further blood pressure decrease was noted.The physician did not conclusively exclude the deflectable sheath as a possible contributing cause of the cardiac tamponade.It was also reported the ablation catheter tip was completely withdrawn into the deflectable sheath.This is contrary to product labeling in which the soft distal tip of the catheter is recommended to be extended from the sheath during sheath movemement.It cannot be determined if this deviation from the instructions from use contributed to this adverse event.

Event Description

During a pulmonary vein isolation procedure to treat atrial fibrillation, a drop in blood pressure occurred and cardiac tamponade was diagnosed with echocardiography.The cardiac tamponade was successfully treated by pericardiocentesis.The physician believes the cause of the cardiac tamponade was an electrophysiology catheter and sheath, made by a different manufacturer, which were used to check for potentials in the right superior pulmonary vein.However, the physician could not exclude the deflectable sheath as a possible cause of the cardiac tamponade.

• 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: 12601476
• MDR Text Key: 275901461
• Report Number: 1225698-2021-00020
• 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: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: 18-3356
• Device Catalogue Number: 18-3356
• Device Lot Number: E2063179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• 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): Other
• Patient Age: 55 YR