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

Lot Number 0032479867

Device Problems Obstruction of Flow (2423); Activation, Positioning or Separation Problem (2906)

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

Event Date 02/07/2024

Event Type  malfunction  

Event Description

During a pulmonary vein isolation (pvi) procedure to treat paroxysmal atrial fibrillation (paf), a farawave catheter was selected for use.The catheter had been prepared per the directions for use and was connected to a heparinized flushing line (5000 units).The left veins were treated, however, when transitioning to the right veins, the catheter was unable to be correctly deployed.The splines were in cobra shape.The catheter was retracted into the sheath and rotated 180 degrees into the straight portion of the sheath.The issue did not correct.The catheter was removed from the patient to be manually checked, when it was observed that the irrigation, flushing through the side port was not working.The catheter was replaced, and the procedure was completed successfully without patient complications.Following the procedure another farawave catheter that was used during the procedure was tested.The physician attached a 10ml syringe to the flush port and attempted to irrigate the catheter.The physician was not able to successfully flush the fluid through the irrigation line at that time.No troubleshooting took place as the procedure had already been completed with no patient complications.The catheters are expected to be returned for analysis.

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.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the catheter was first visually inspected, and no abnormalities were found.In basket deployment, an external force was applied to each spline to see if they would invert.Some of the splines inverted easily, which aligns with the reported issue concerning a proper deployment shape.A guidewire was successfully advanced through the catheter and deployment of the array was tested and found to be without defect.Flushing of the device through the irrigation line was also tested.Flushing could be achieved in the undeployed and basket configurations, but not in the flower configuration.The catheter was dissected and revealed the flush kinked, likely causing the flushing difficulties.

Event Description

During a pulmonary vein isolation (pvi) procedure to treat paroxysmal atrial fibrillation (paf), a farawave catheter (bsc ref: (b)(4)) was selected for use.The catheter had been prepared per the directions for use and was connected to a heparinized flushing line (5000 units).The left veins were treated, however, when transitioning to the right veins, the catheter was unable to be correctly deployed.The splines were in cobra shape.The catheter was retracted into the sheath and rotated 180 degrees into the straight portion of the sheath.The issue did not correct.The catheter was removed from the patient to be manually checked, when it was observed that the irrigation/flushing through the side port was not working.The catheter was replaced, and the procedure was completed successfully without patient complications.Following the procedure another farawave catheter (bsc ref: (b)(4)) that was used during the procedure was tested.The physician attached a 10ml syringe to the flush port and attempted to irrigate the catheter.The physician was not able to successfully flush the fluid through the irrigation line at that time.No troubleshooting took place as the procedure had already been completed with no patient complications.The catheters were returned for analysis.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER
• 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): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18714658
• MDR Text Key: 335856904
• Report Number: 2124215-2024-08587
• 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
• Device Lot Number: 0032479867
• 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: 04/17/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2023
• 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
• Treatment: FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM; FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM