MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT X3 CATHETER

Model Number 18-5000 (EU)

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned but photographs were provided.The failure of the tip appears to be mechanical separation.If the failure is confirmed to be mechanical separation, this would be the first instance of this failure mode.However, the failure mode cannot be confirmed until the device has been returned.Batch record review of the components used and the manufacturing process has found no nonconformances that might be related to this event.Any other devices made in the same lot as the complaint device would now be expired.This is an initial report.A follow-up report will be submitted when the returned device has been examined.

Event Description

During a pulmonary vein isolation procedure to treat atrial fibrillation, when the physician removed the catheter at the end of the procedure the distal end of the of catheter remained in a branch of the right inferior vein.The physician confirmed the end of the catheter remained in the vein with x-ray and echocardiography.The distal end of the catheter was removed using a different catheter.There was no patient complication reported.It was reported the patient had a small left atrium and that it was difficult to access the right inferior pulmonary vein, which was the last vein treated.

• Brand Name: HEARTLIGHT
• Type of Device: HEARTLIGHT X3 CATHETER
• 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: 13080225
• MDR Text Key: 287022835
• Report Number: 1225695-2021-00033
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P150026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 18-5000 (EU)
• Device Catalogue Number: 18-5000 (EU)
• Device Lot Number: 13426-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• 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