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

Device Problems Entrapment of Device (1212); Material Twisted/Bent (2981)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that during an irreversible electroporation ablation procedure using a farawave catheter the guidewire became stuck in the guidewire lumen.It was noted during the ablation that the "flower position stays deployed forwards".After ablation of the left inferior pulmonary vein (lipv) they attempted to move the catheter to the left superior pulmonary vein (lspv).The guidewire advanced a little bit and then would not advance any further.They pulled the guidewire back and attempted to advance it again, but they were unable to do so.They exchanged the catheter, and the issue was resolved.When examined outside of the body they did not see any tissue on the catheter tip or guidewire.The procedure was then completed with no patient complications.The catheter is expected to be returned for analysis.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the catheter was visually inspected, and no abnormalities were observed.The catheter was returned with the original guidewire inserted.Functional testing was performed, and the original guidewire returned with the catheter was able to be advanced and withdrawn through the catheter with no issue.The catheter's array was also able to be deployed and undeployed with no resistance.Additionally, there was no tissue or foreign matter found on or in the catheter tip.However, in flower deployment, poor planarity was noted, and the device did not pass the planarity test.It was observed that some splines were thinner and consequently resulted in a steeper takeoff angle at the location of the distal thermal weld.

Event Description

It was reported that during an irreversible electroporation ablation procedure using a farawave catheter the guidewire became stuck in the guidewire lumen.It was noted during the ablation that the "flower position stays deployed forwards".After ablation of the left inferior pulmonary vein (lipv) they attempted to move the catheter to the left superior pulmonary vein (lspv).The guidewire advanced a little bit and then would not advance any further.They pulled the guidewire back and attempted to advance it again, but they were unable to do so.They exchanged the catheter, and the issue was resolved.When examined outside of the body they did not see any tissue on the catheter tip or guidewire.The procedure was then completed with no patient complications.The catheter has been returned for analysis.

• 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 ; CA
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18712753
• MDR Text Key: 335856657
• Report Number: 2124215-2024-08868
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 05/08/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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