MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARASTAR; ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, SINGLE USE

Model Number	M004PF41M434
Medical Device Problem Codes	Contamination (1120); Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sterile packaging of a farastar catheter connection cable was easily damaged during opening.During preparation for a procedure, a farastar catheter connection cable was selected for use.However, while preparing the device, the sterile packaging tore apart.The original device was used to complete the procedure.No patient complications were reported.It is unknown if the packaging will 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.
Additional Manufacturer Narrative
Neither the cable nor the packaging was returned to boston scientific for investigation, however, images of the damaged packaging were provided.Investigators were able to see that the packaging had a tear through the middle of the plastic.Based on all the available information investigators concluded that the most likely cause of the tear in the packaging was unintended user error.Based on the visual nature of the tear it was most likely the result to force exerted by the user when attempting to open the packaging.
Event or Problem Description
It was reported that the sterile packaging of a farastar catheter connection cable was easily damaged during opening.During preparation for a procedure, a farastar catheter connection cable was selected for use.However, while preparing the device, the sterile packaging tore apart.The original device was used to complete the procedure.No patient complications were reported.It is unknown if the packaging will return for laboratory analysis.

• Brand Name: FARASTAR
• Common Device Name: ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, SINGLE USE
• 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: 23049171
• Report Number: 2124215-2025-64509
• Device Sequence Number: 9747026
• Product Code: QZI
• UDI-Device Identifier: 00191506041656
• UDI-Public: (01)00191506041656(17)261009(10)35029892
• 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): 01/28/2026

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: 0035029892
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 01/28/2026
• Date Device Manufactured: 10/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male