MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM? -14; WIRE, GUIDE, CATHETER

Model Number	M001508140
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Boston scientific has been unable to obtain additional information regarding the patient outcome, despite good faith efforts.
Event or Problem Description
It was reported that a tip detachment occurred.A 300 cm x 10 cm fathom -14 was selected for use.During the procedure, the end of the guidewire detached while in the artery and was left with the patient.

• Brand Name: FATHOM? -14
• 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: 24421469
• Report Number: 2124215-2026-09943
• Device Sequence Number: 18793656
• Product Code: DQX
• UDI-Device Identifier: 08714729801047
• UDI-Public: (01)08714729801047(17)280917(10)37488270
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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
• Report Date (Section B): 02/23/2026

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: M001508140
• Device Catalogue Number: M001508140
• Device Lot Number: 0037488270
• 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: 01/27/2026
• Initial Report FDA Received Date: 02/23/2026
• Date Device Manufactured: 09/18/2025
• 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 Sex: Unknown