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

Model Number	M001509100
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that wire stuck and fractured occurred.A 16.016 perph gw 180x25cm fathom was selected for use in a pseudo aneurysm embolization.During the procedure, the wire did not maintain its shape after manual shaping.Upon insertion into the microcatheter, resistance was noted.When the fathom wire was subsequently withdrawn, it initially appeared stuck, then released abruptly and fractured.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
G4 - premarket / 510(k) #: k111485, k170636.Device evaluated by mfr: the device was returned for analysis,, and the evaluation was completed.Visual inspection was performed, and it was observed that the distal tip was returned detached, but the detached section was not returned for analysis.The device was inspected under magnification, and it was possible to see that the distal tip was detached, and the core wire was kinked.Additionally, the polytetrafluoroethylene (ptfe) coating at the proximal section was peeled.Since a detachment occur and the rest of the tip did not return for analysis, a dimensional inspection was not able to be conducted.
Event or Problem Description
It was reported that wire stuck and fractured occurred.A 16.016 perph gw 180x25cm fathom was selected for use in a pseudo aneurysm embolization.During the procedure, the wire did not maintain its shape after manual shaping.Upon insertion into the microcatheter, resistance was noted.When the fathom wire was subsequently withdrawn, it initially appeared stuck, then released abruptly and fractured.There were no patient complications as a result of this event.

• 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 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23301257
• Report Number: 2124215-2025-72289
• Device Sequence Number: 11977963
• Product Code: DQX
• UDI-Device Identifier: 08714729762553
• UDI-Public: (01)08714729762553(17)280806(10)37153122
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K111485
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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: 0037153122
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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