MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE; See H11

Lot Number	0038834798
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
During a procedure, a farawave catheter was selected for use.Upon deployment after insertion into the patient, a spline inversion occurred and could not be corrected while the catheter was in situ.The catheter was therefore replaced, and the procedure was completed successfully with no complications reported during case.Following the procedure, the patient developed gastric distention and was hospitalized.The condition resolved by the following day, and the patient was subsequently discharged.At the time of reporting, the underlying cause of the gastric dilatation remained unknown.

• Brand Name: FARAWAVE
• Common Device Name: See H11
• 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 ; +1(651)440-0979
• MDR Report Key: 50599638
• Report Number: 2124215-2026-47197
• Device Sequence Number: 21371445
• Product Code: QZI
• UDI-Device Identifier: 00191506043216
• UDI-Public: (01)00191506043216(17)270314(10)38834798
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Lot Number: 0038834798
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown