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

Model Number	M004PF41M434
Medical Device Problem Codes	Contamination (1120); 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	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a farastar catheter connection cable was selected for use.During cable preparation, the sterile packaging did not tear in the correct place and the packaging tore down the middle of the paper resulting in the cable falling out and becoming unsterile.It was noted that there is "poor quality of sterile packaging".The device was replaced, and the procedure was completed successfully.No patient complications were reported.The device is expected to return for laboratory analysis.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a farastar catheter connection cable was selected for use.During cable preparation, the sterile packaging did not tear in the correct place and the packaging tore down the middle of the paper resulting in the cable falling out and becoming unsterile.It was noted that there is "poor quality of sterile packaging".The device was replaced, and the procedure was completed successfully.No patient complications were reported.The device was returned for laboratory analysis.
Additional Manufacturer Narrative
Device evaluated by mfr.: upon receipt at boston scientific's post market laboratory, the returned packaging was visually inspected.Visual inspection noted that the packaging was torn along the edge of the paper.It is possible that the force applied by the user could have caused the packaging to tear improperly and for the farastar cable to fall out of the packaging.

• 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 ; 6514400979
• MDR Report Key: 22793438
• Report Number: 2124215-2025-56283
• Device Sequence Number: 8643452
• Product Code: QZI
• UDI-Device Identifier: 00191506041656
• UDI-Public: (01)00191506041656(17)261024(10)35139707
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: M004PF41M434
• Device Catalogue Number: M004PF41M434
• Device Lot Number: 0035139707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male