MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE NAV; No Match

Lot Number	0036023072
Medical Device Problem Codes	Difficult to Remove (1528); Blocked Connection (2888); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
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 with all the available information, boston scientific concludes the reported observation of difficult to advance guidewire, obstruction within device and difficult to withdraw guidewire were confirmed through investigational analysis.Upon device return and inspection, it was noted that the catheter was returned with a stuck guidewire still inserted.Microscopy revealed dried blood, potentially mixed with some tissue, on the guidewire at the distal end.It is believed that this was likely caused by the advancement or retraction of the guidewire engaging with some tissue.Device history record (dhr) review the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Labeling review a warning is issued in the device labeling regarding tissue or vessel damage when advancing or retracting components.The ifu provides a warning that if resistance is felt during retraction of the guidewire, do not continue to retract the guidewire until cause of resistance is determined as this may result in cardiac trauma.Risk review a risk review performed for the farawave device confirmed that the event of difficult to advance guidewire, obstruction within device and difficult to withdraw guidewire are known events defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the farawave device is acceptable.Investigation conclusion boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event and supporting evidence that came to this conclusion.Based on all the available information difficult to advance guidewire, obstruction within device and difficult to withdraw guidewire was likely due to unintended use error caused or contributed to event, the cause of the guidewire becoming stuck was found to be tissue that was stuck in the guidewire, at the distal end.
Event or Problem Description
It was reported that, for the farawave procedure for atrial fibrillation, the device was prepped and tested on back table with no issues.The device inserted into left atrium (la) by the physician.The wire advanced into left superior pulmonary vein (lspv) and the catheter functioned properly during delivery of flower and basket pulses.When attempting to advance wire into the lspv, the patient experienced increased resistance.Visualizing the wire and flower on ice, he continued to attempt to advance and retract the wire.He still noted an unusual amount of resistance.He stated, "something isn't right with this catheter." so, he removed the catheter from the body.The guidewire resistance was so much that he could actually hold the entire catheter up while grasping nothing but the wire.The scrub tech attempted to deploy the catheter into basket (with the wire out the distal tip), and the guidewire lumen bent.We replaced with another 35mm catheter and finished the procedure with no other issues.No patient complications occurred.The device was received for analysis.

• Brand Name: FARAWAVE NAV
• 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: 24634514
• Report Number: 2124215-2026-15133
• Device Sequence Number: 18317210
• Product Code: QZI
• UDI-Device Identifier: 00191506043209
• UDI-Public: (01)00191506043209(11)250308(17)260308(10)36023072
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 03/18/2026

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: 03/08/2026
• Device Lot Number: 0036023072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 7 MO
• Patient Sex: Unknown