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

Model Number	M004PF61M601
Medical Device Problem Codes	Device Sensing Problem (2917); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that farastar msm nam was selected for use.It has been mentioned that the first issue was map shifting without patient movement.Tried to adjust the magnet physically to line up the map yet no improvement.Second issue was that while ablating, catheter started to disappear on the screen after about 50-60 ablations.Map shift issue occurred again.Using an external reference and it was routed through the rsm.During one of the cases during the procedure, a lab staff member placed the baylis generator on top of the msm.No errors occurred on the opal system.No patient complications have been reported.The procedure was cancelled.The product is not expected to be returning.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: FARASTAR
• Common Device Name: NO MATCH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 24663016
• Report Number: 2124215-2026-15756
• Device Sequence Number: 9243924
• Product Code: QZI
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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
• Device Model Number: M004PF61M601
• Device Catalogue Number: M004PF61M601
• Device Lot Number: 0107874039
• 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: 03/01/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 07/06/2026
• Date Device Manufactured: 03/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown