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

Model Number	M001509100
Medical Device Problem Codes	Fracture (1260); Stretched (1601); Unraveled Material (1664); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 180x25cm fathom -16 guidewire was selected for use in a renal embolization.During the procedure, the guidewire fractured in addition to being stretched and unraveled.The procedure was completed using an alternate method.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that shaft break occurred.A 180x25cm fathom -16 guidewire was selected for use in a renal embolization.During the procedure, the guidewire fractured in addition to being stretched and unraveled.The procedure was completed using an alternate method.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
The gw fathom periph was not returned but device analysis was performed using the photo received.It was possible to observed that the polymer jacket was peeled, stretched and detached at the distal tip.

• 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: 22568356
• Report Number: 2124215-2025-48575
• Device Sequence Number: 14432145
• Product Code: DQX
• UDI-Device Identifier: 08714729762553
• UDI-Public: (01)08714729762553(17)280226(10)35948344
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: 0035948344
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/29/2025
• Date Device Manufactured: 02/26/2025
• 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