MAUDE Adverse Event Report: FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number 0008021410

Device Problem Positioning Failure (1158)

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

Event Date 01/03/2024

Event Type  malfunction  

Manufacturer Narrative

The farawave catheter was returned to boston scientific for analysis.Upon receipt at our post market quality assurance laboratory the device underwent visual inspection, x-ray inspection, and functional testing.No outer abnormalities were observed.The device was put on the x-ray to look for any potential abnormalities that could have contributed to deployment issues, but no anomalies were noted.The device was returned with a guidewire inserted.An attempt was made to deploy the catheter.While moving the slider switch, the spline cage remained undeployed.It was observed that the guidewire lumen was no longer adhered to the tip of the spline cage.The device was dissected to look for any abnormalities that could have contributed to the delamination of the guidewire lumen.Nothing out of the ordinary was noted.The reported clinical observations were confirmed by the analysis.

Event Description

It was reported that during an ablation procedure to treat atrial fibrillation a farawave pulsed field ablation catheter was selected for use.During the 8th ablation delivery to the right inferior pulmonary vein (ripv), the 24th in total, after 15 minutes in the left atrium (la) the catheter spontaneously undeployed from the basket formation.The physician did not have his hand on the deployment slider switch at the time and the undeployment was not intentional.Prior to the undeployment there was no difficulty with deployment or the slider switch when operating in the previous pulmonary veins (pvs).The slider switch was sitting approximately at the basket marker on the handle, yet the array under fluoroscopy was noted to be completely undeployed and advanced further into the ripv than desired.The catheter was successfully recaptured back into the sheath and removed from patient.The catheter was replaced and the procedure was completed.No patient complications were reported.The farawave catheter was returned to boston scientific for analysis.Upon receipt at our post market quality assurance laboratory it was found that the guidewire lumen was no longer adhered to the tip of the spline cage while testing deployment, resulting in the inability to deploy the catheter.The guidewire lumen was originally bonded to the tip, but failed, and is now preventing the deployment of the spline cage when the slider is pulled back.It is unknown how the bond was broken or failed.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
• Type of Device: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
• Manufacturer (Section D): FARAPULSE, INC.; 3715 haven avenue; suite 110; menlo park CA 94025
• Manufacturer (Section G): AGILE MV INC; 3700 st patrick st suite 102; montreal, qc H4E 1 A2; CA H4E 1A2
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19080197
• MDR Text Key: 339905979
• Report Number: 2124215-2024-20954
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0008021410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1