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 03/02/2022

Event Type  malfunction  

Event Description

During a pulmonary vein isolation procedure to treat atrial fibrillation, the two left sided pulmonary veins were successfully isolated.The physician tried to gain access to the right inferior pulmonary vein (ripv) but was unable to get good balloon/tissue contact because the ripv immediately split into 3 smaller veins.The sheath and catheter were highly deflected in an attempt to gain contact.The catheter was deflated and withdrawn into the introducer sheath, at which point the introducer sheath and the catheter slid into the right atrium.The distal catheter assembly was then observed to be detached from the catheter shaft.The detached distal catheter assembly was retrieved with a snare.The optic window of the catheter was broken and the balloon was torn.Tearing the balloon component of the catheter requires considerable force.There was no adverse effect on the patient reported.

Manufacturer Narrative

Investigation into the returned device confirmed the report of a detached distal assembly.The proximal end of the optic window component of the catheter was broken.If the sheath is highly deflected with the optic window in the zone of deflection then damage to the optic window may occur.In order for the distal catheter assembly to detach, two independent failures must occur in that both the optic window has to be broken and the balloon has to be torn.Tearing the balloon requires the user to pull the catheter back into the sheath with considerable force.This isa double fault event where breaking of the optic window and tearing of the balloon are independent events.Users are trained to avoid pulling hard on the catheter while retracting the catheter into the sheath.The complaint report noted that during balloon inflation, fluid was seen entering the balloon from the distal end of the catheter shaft in the area of the proximal end of the optic window.Ordinarily, fluid would only enter the balloon from the distal end of the optic window.This observation indicates there may have been a break in the proximal end of the optic window at the start of the case which would allow fluid to enter the balloon from the distal end of the catheter.However, this possibility cannot be confirmed from the returned device and it is possible that the broken optic window was due to extreme clinical use without any defect in the catheter.No other reports of fluid entering the balloon during catheter preparation from the distal end of the catheter have been received by cardiofocus.A review of manufacturing records found no deficiencies in the manufacturing of the catheter.

• 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: 13934732
• MDR Text Key: 290374802
• Report Number: 1225698-2022-00005
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150026
• 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: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 18-5000 (EU)
• Device Catalogue Number: 18-5000 (EU)
• Device Lot Number: 16301-007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2021
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Race: White