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

Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
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.Detailed product information was not provided to bsc.Good faith efforts to obtain the information are in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information at this time.A supplemental report will be filed if the information is received.Investigation summary: it was indicated that the device was available for return, however the device has not been received; therefore, a technical analysis of the complaint device could not be completed.Boston scientific has made three attempts to retrieve the device however no response was received; the device is not expected to be returned; 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 thing risk documentation was completed and confirmed that the event of a stuck guidewire 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 unable to exclude device problem as the cause of the reported issue cannot be established due to lack of evidence.
Event or Problem Description
It was reported that during an atrial fibrillation ablation a farawave was selected for use.During procedure, advancing the merit rosen wire was difficult.Troubleshooting was performed by changing the wire however, the issue was not resolved.The catheter was replaced and the procedure was completed without patient complications.The device is expected to be returned for laboratory analysis.
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.Detailed product information was not provided to bsc.Good faith efforts to obtain the information are in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information at this time.A supplemental report will be filed if the information is received.
Event or Problem Description
It was reported that during an atrial fibrillation ablation, a farawave was selected for use.During procedure, advancing the merit rosen wire was difficult.Troubleshooting was performed by changing the wire; however, the issue was not resolved.The catheter was replaced and the procedure was completed without patient complications.The device is expected to be returned for laboratory analysis.

• Brand Name: FARAWAVE PFA CATHETER
• Common Device Name: NO MATCH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 24426043
• Report Number: 2124215-2026-10049
• Device Sequence Number: 21296895
• Product Code: QZI
• UDI-Device Identifier: 00191506043155
• UDI-Public: (01)00191506043155
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/06/2026
• 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
• Patient Sex: Unknown