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

Lot Number	0036197535
Medical Device Problem Codes	Contamination (1120); Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for the farawave procedure for paroxysmal atrial fibrillation, on the first catheter the flush port did not appear clear.It had a milky-white appearance to it.When flushing was tried in the lumen that hangs off the handle, no saline would advance.A second catheter was used, and this one had the same cloudy appearance.There also appeared to be extra glue at the end of the catheter as well.Flushing this catheter was difficult as well.The first two catheters had the same lot number.A third catheter was opened it also had the same appearance; with visual inspection it appeared the glue was cracking inside the lumen of the flush part when moving the flexible portion.It even felt crackly.At this point a piece flaked off where the port enters the blue portion of the catheter.The fourth catheter opened was a farawave 35mm with the same appearance and did not flush.A fifth catheter was opened with the same appearance of not being clear and it did not flush either.This catheter tubing was cut open for inspection, and it was noticed a long bead of glue sticking out as the outside edges were cut and pulled apart.10 more catheters were opened one at a time and inspected for glue and cloudy appears, and all tested for flushing.Not a single one had the normal clear appearance or was able to be flushed without force.The 16th catheter was used to complete the procedure.No patient complications occurred.The devices are expected to be returned.
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.The device has not been received for analysis.Upon receipt and completion of the analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• Brand Name: FARAWAVE
• 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: 24282623
• Report Number: 2124215-2026-06977
• Device Sequence Number: 9927346
• Product Code: QZI
• UDI-Device Identifier: 00191506043155
• UDI-Public: (01)00191506043155(17)270401(10)36197535
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/25/2026

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 Lot Number: 0036197535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown