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

Model Number	M004PF61M415
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Once the cable is removed from the packaging the user is not able to track the batch number, therefore they were unable to provide this information to boston scientific.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 a procedure was cancelled.It was reported that during preparation for a pulsed field ablation (pfa) procedure a farastar rsm ecg trunk cable - aami was selected for use.However, the cable went out and a noise was observed.The procedure was cancelled due to this issue.No more information was provided.It's unknown if the device will return for laboratory analysis.

• 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: 25167790
• Report Number: 2124215-2026-26064
• Device Sequence Number: 10182039
• 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
• Report Date (Section B): 09/15/2026

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: 04/21/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 09/15/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown