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

Lot Number 0008021709

Device Problems Activation, Positioning or Separation Problem (2906); Improper Flow or Infusion (2954); Material Twisted/Bent (2981)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

It was reported that when opened into basket or flower, the catheter splines were tangled/intertwined.There was also an issue with irrigation.During a pulmonary vein isolation (pvi) ablation procedure, a farawave ablation catheter was selected for use.When deployed into basket or flower, the splines became tangled/intertwined.In addition, when the catheter was open, an occlusion alarm alerted on the flushing pump and the device could not be flushed.The device was manipulated in an attempt to untangle the splines but was unsuccessful.Upon successful withdrawal from the patient, there was visible spline inversion, which manually un-inverted outside of the patient anatomy.The sheath was straight during retraction into the sheath.The catheter had not been deployed without a guidewire inserted and it was confirmed that the guidewire was advanced past the catheter during deployment/undeployment.A non-boston scientific extra stiff 3mm j tip wire was utilized.The farawave did not become entangled with any other catheters during the procedure.It was noted that the patient did have small atrial anatomy.The catheter had been pulled back from the tissue when rotating the array between ablations.The catheter was replaced, and the procedure was completed successfully without patient complications.The device has been deemed contaminated by the facility and will not be returned for analysis.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• 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: 18886974
• MDR Text Key: 337565310
• Report Number: 2124215-2024-14650
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 03/12/2024

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: 0008021709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1