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

Model Number	M001509100
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a tips [transjugular intrahepatic portosystemic shunt] procedure, a short segment of a 0.16 fathom microwire sheared off and was retained within the hepatic parenchyma.This wire fragment sheared from a 0.18" guidewire and appeared to be embedded in the liver parenchyma adjacent to the intrahepatic portal vein.Patient stable following procedure.

• Brand Name: FATHOM¿ -16
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 24115655
• Report Number: 24115655
• Device Sequence Number: 5890756
• Product Code: DQX
• UDI-Device Identifier: 08714729762553
• UDI-Public: (01)08714729762553(17)281008(10)3766943
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/10/2025
• Report Date (Section F): 12/10/2025

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: M001509100
• Device Catalogue Number: M001509100
• Device Lot Number: 3766943
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/10/2025