MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARASTAR?; percutaneous cardiac ablation catheter for treatment of atrial fibrillation

Model Number	M004PF61M415
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Good faith effort to obtain the information is currently in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.
Event or Problem Description
It was reported that the representative contacted the team while the patient was on the table due to ecg noise observed in non-bsc devices while using the farastar rsm cable.Connections and ecg/egm signals were promptly reviewed.The team had previously replaced the ra lead on the rsm cable, which provided partial improvement.The patient had initially been considered for a study requiring high-quality ecg signals; however, during the call, the patient was originally being considered for a study that needed good ecgs, during the call the patient was ruled out for the study.This event is being reported for a canceled/aborted procedure.
Additional Manufacturer Narrative
Investigation summary with all the available information, boston scientific is unable to confirm cause of the reported clinical observation of a090801 signal artifact/noise.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.Device history record review it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).Risk review a risk review performed for the farastar accessories device confirmed that the event of a090801 signal artifact/noise is a known event defined in the product risk management 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 and supporting evidence that came to this conclusion.Boston scientifics investigation findings were unable to establish a clear conclusion about the cause of the reported event.The device met all requirements prior to being approved for final distribution/sale and there was no evidence to suggest that the instructions for use (ifu) was not followed.
Event or Problem Description
It was reported that the representative contacted the team while the patient was on the table due to ecg noise observed in non-bsc devices while using the farastar rsm cable.Connections and ecg/egm signals were promptly reviewed.The team had previously replaced the ra lead on the rsm cable, which provided partial improvement.The patient had initially been considered for a study requiring high-quality ecg signals; however, during the call, the patient was originally being considered for a study that needed good ecgs, during the call the patient was ruled out for the study.This event is being reported for a canceled/aborted procedure.It was further confirmed that the procedure was not canceled and was completed successfully without patient complications.

• Brand Name: FARASTAR?
• Common Device Name: percutaneous cardiac ablation catheter for treatment of atrial fibrillation
• 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 ; +1(651)440-0979
• MDR Report Key: 25260037
• Report Number: 2124215-2026-27787
• Device Sequence Number: 16087529
• Product Code: QZI
• UDI-Device Identifier: 00191506042981
• UDI-Public: (01)00191506042981
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P230030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/14/2026

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 Model Number: M004PF61M415
• Device Catalogue Number: M004PF61M415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 05/21/2026; 06/19/2026; 08/26/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 06/11/2026; 07/06/2026; 09/14/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown