MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARASTAR; Cardiac Irreversible Electroporation System Generator

Model Number	M004PF41M444
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During preparation for a pulse field ablation procedure, a farastar catheter connection cable was selected for use.The package was difficult to open, and while attempting to remove the cable, one end flipped out of the packaging and contacted a non-sterile surface.The device was considered contaminated and was replaced.The procedure was completed successfully with no patient injury or complications.
Event or Problem Description
During preparation for a pulse field ablation procedure, a farastar catheter connection cable was selected for use.The package was difficult to open, and while attempting to remove the cable, one end flipped out of the packaging and contacted a non-sterile surface.The device was considered contaminated and was replaced.The procedure was completed successfully with no patient injury or complications.It was further reported that the event occurred prior to the patient's arrival in the procedure room.The device was disposed.
Additional Manufacturer Narrative
Additional information, b5, updated.Investigation summary.With all the available information, boston scientific is unable to confirm cause of the reported clinical observation of packaging.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.However, boston scientific was able to determine the cause of the reported event not sterile as the event description stated: the difficulty in opening the package made one end of the cable flip out and touch something that got it contaminated and lost sterility, indicating that the cause of the loss of sterility was due to inadvertently letting the cable come in contact with something (that could have potentially contaminated the cable) while opening the package.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.Risk review.A risk review performed for the farastar connection cable device confirmed that the event of packaging, and not sterile are known events 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.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).Investigation conclusion.Boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event and cause not established and supporting evidence that came to this conclusion.Boston scientific investigation findings were unable to establish a clear conclusion about the cause of the reported event of packaging.However, was able to determine the cause of the reported event not sterile.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.

• 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 25243967
• Report Number: 2124215-2026-27463
• Device Sequence Number: 10534761
• Product Code: QZI
• UDI-Device Identifier: 00191506041663
• UDI-Public: (01)00191506041663(17)260929(10)37571684
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 09/25/2026

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 Expiration Date: 09/29/2026
• Device Model Number: M004PF41M444
• Device Catalogue Number: M004PF41M444
• Device Lot Number: 0037571684
• 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: 05/19/2026; 09/22/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/10/2026; 09/25/2026
• Date Device Manufactured: 09/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown