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

Lot Number 0008021431

Device Problem Material Integrity Problem (2978)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

Upon device return and inspection, 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.A guidewire was inserted through the device and 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.Based on the available information, boston scientifics investigation findings determined that the cause of the deployment difficulties.Was due to component failure due to the observed failed guidewire lumen tip bond, which is assumed to be the reason for the allegation of a failure 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's unknown how the bond was broken or failed.

Event Description

Reportable based on analysis completed on (b)(6)2024 during an ablation procedure a farawave pulsed field ablation catheter was selected for use.It was reported that when moving from basket to flower configuration for right superior pulmonary vein ablation the deployment mechanism broken.The catheter was replaced, and at the first deployment inside the body the mechanism broken too.A third catheter was used to complete the procedure.No patient complications were reported.No issues with flushing.No abnormalities were experienced during preparation.The catheter was undeployed when retracted into the sheath.Patient had standard anatomy.The devices have been returned for laboratory analysis.However, analysis of the returned device revealed that the guidewire lumen was no longer adhered to the tip of the spline cage.

• 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: 19212859
• MDR Text Key: 341590849
• Report Number: 2124215-2024-25680
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/30/2024

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: 0008021431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1