MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE PFA CATHETER; NO MATCH

Lot Number	0034636473
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for an ablation procedure, one farawave catheter was selected for being used when the flower petals were deflected; they were sharp, not round and the plastic looked to be stretched and cracking.The device was replaced, and the procedure was completed without patient complications.The device is not expected to return for laboratory analysis since it was disposed.
Additional Manufacturer Narrative
D2a: common device name: percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation; reported here as the common device name exceeded the character limit for designated field.
Additional Manufacturer Narrative
D2a: common device name: percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation; reported here as the common device name exceeded the character limit for designated field.Investigation summary: it was indicated that the device was disposed; therefore, a technical analysis of the complaint device could not be completed.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the farawave's risk documentation was completed and confirmed that the event of damaged splines was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific has assigned an investigation conclusion code of cause not established as the cause of the reported issue cannot be established due to lack of evidence.
Event or Problem Description
It was reported that during preparation for an ablation procedure one farawave catheter was selected for being used, when the flower petals were deflected, they were sharp not round and the plastic looked to be stretched and cracking.The device was replaced, and the procedure was completed without patient complications.The device is not expected to return for laboratory analysis since it was disposed.It was further reported that the splines were not rounded at the tip of each flower petal, they were sharp.Plastic was white at the vertex as if the plastic had stretched.

• Brand Name: FARAWAVE PFA CATHETER
• Common Device Name: NO MATCH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway,; global park; la aurora - heredia ; CS
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 24630999
• Report Number: 2124215-2026-14877
• Device Sequence Number: 18375813
• Product Code: QZI
• UDI-Device Identifier: 00191506043155
• UDI-Public: (01)00191506043155(17)260814(10)34636473
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2026
• Device Lot Number: 0034636473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/07/2026
• Date Device Manufactured: 08/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown