MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARASTAR; CATHETER CONNECTION CABLE

Model Number	M004PF41M434
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, upon opening the box for the farastar catheter connection cable, the sterile seal was already opened.The cable was unable to be used for the procedure as it was not sterile and therefore replaced.The procedure was completed and there were no patient complications.The cable is not expected to return for analysis as it was disposed.
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.
Additional Manufacturer Narrative
Additional information was provided in section b5 describe event or problem 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.
Event or Problem Description
It was reported that during a procedure, upon opening the box for the farastar catheter connection cable, the sterile seal was already opened.The cable was unable to be used for the procedure as it was not sterile and therefore replaced.The procedure was completed and there were no patient complications.The cable is not expected to return for analysis as it was disposed.It was further reported, additional information received indicated that no damage was noted on the outer box.Left side of the inner pouch was only partially sealed, however outer box was sealed properly.No additional damage noted on the inner packaging/pouch.

• Brand Name: FARASTAR
• Common Device Name: CATHETER CONNECTION CABLE
• 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: 21474853
• Report Number: 2124215-2025-12029
• Device Sequence Number: 14344501
• Product Code: QZI
• UDI-Device Identifier: 00191506041656
• UDI-Public: (01)00191506041656(11)241127(17)261127(10)35376211
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 04/18/2025

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: M004PF41M434
• Device Catalogue Number: M004PF41M434
• Device Lot Number: 0035376211
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 04/18/2025
• Date Device Manufactured: 11/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown