MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARASTAR; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM GENERATOR

Model Number	M004PF61M601
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts were made to try and retrieve the device status, but it was not obtained.
Event or Problem Description
It was reported that during a pulsed field ablation (pfa) procedure the farastar msm nam was selected for use, during faraview case.During the case, the mapper observed error 301 while attempting to deliver pfa initially.Mapper confirmed all connections which did not resolve the issue.Mapper then exchanged catheter which did not resolve the issue.The mapper rebooted the entire system.Mapper again confirmed that console to stim cable was connected and secure, the rsm to msm aux cable was connected and secure, and both rsm and msm were powered on and in a ready state (not test mode).Mapper then delivered therapy successfully.Mapper tried to deliver therapy a second time and again got 301.Physician assured good catheter position and again attempted to delivery therapy which again produced a 301 error.The catheter was then connected directly to the farastar console (bypassing the msm).The team was able to delivery therapy successfully three times in a row.No patient complications were reported.It is unknown if the farastar device is expected to be returned.It was further reported that the case was cancelled mid-procedure because the opal mapping system couldn't be used; only ice and fluoroscopy were available.Although the catheter connected to the console, the physician decided not to continue without mapping integration.After 45 minutes of troubleshooting, it was determined that the msm or aux cable was faulty.Fse testing later confirmed the msm waveform was out of tolerance, causing the farastar to throw a 301 error.The first catheter replacement was due to persistent spline inversion, and the second was in response to the 301 error, assuming it was catheter-related.The gen 2 cable was replaced once to troubleshoot the persistent console error.However, neither catheter nor cable replacement resolved the issue.The msm was confirmed defective and was the true cause.Only two catheters were swapped.The sheath was not defective, but the case was canceled because opal was non-functional and essential for navigation.

• Brand Name: FARASTAR
• Common Device Name: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM GENERATOR
• 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: 22214586
• Report Number: 2124215-2025-39519
• Device Sequence Number: 8659353
• Product Code: QZI
• UDI-Device Identifier: 00191506043841
• UDI-Public: (01)00191506043841(11)250324
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/16/2025

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: 0107931729
• 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: 05/21/2025
• Initial Report FDA Received Date: 06/16/2025
• Date Device Manufactured: 03/24/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown