MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM? -16; WIRE, GUIDE, CATHETER

Model Number	M001509100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via attached voluntary medwatch report #0504240000-2025-8016 that guidewire fracture occurred, resulting in an unretrieved device fragment.The target lesion was located in the hepatic parenchyma.A 180x25cm fathom? -16 guidewire was selected for use.During the transjugular intrahepatic portosystemic shunt (tips) procedure, a short segment of the the guidewire sheared off, and appeared embedded in the parenchyma, adjacent to the intrahepatic portal vein.There were no patient complications as a result of this event, and the patient was stable following the procedure.

• Brand Name: FATHOM? -16
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24370078
• Report Number: 2124215-2026-08923
• Device Sequence Number: 4770708
• Product Code: DQX
• UDI-Device Identifier: 08714729762553
• UDI-Public: (01)08714729762553(17)281008(10)37664943
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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: M001509100
• Device Catalogue Number: M001509100
• Device Lot Number: 0037664943
• 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: 01/20/2026
• Initial Report FDA Received Date: 02/17/2026
• Date Device Manufactured: 10/09/2025
• 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: 48 YR
• Patient Sex: Unknown