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

Model Number	M001508110
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire fracture occurred.The non-stenosed target lesion was located in the moderately tortuous and non-calcified vessel.A 200cm x 10cm gw fathom-14, angled tip guidewire was selected for embolization of intracranial aneurysm.During the procedure, the distal end of the guidewire was fractured when it reached the middle cerebral artery.The length of the fractured guidewire was approximately 7cm.The guidewire was simply pulled out, and the fractured guidewire was removed.The procedure was completed with another of the same guidewire.There were no patient complications as a result of this event, and the patient was stable post-procedure.
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the gw fathom periph device was returned to our post market quality assurance laboratory.Visual and microscopic inspection of the device was performed and identified that the guidewire distal tip returned detached.The device was inspected under magnification, and it was possible to see that the guidewire distal tip was detached.However, it was not possible to observe any stretched in the distal tip only the detachment.This concludes the product analysis.
Additional Manufacturer Narrative
E.1.- initial reporter address 1 and phone: (b)(6).
Event or Problem Description
It was reported that guidewire fracture occurred.The non-stenosed target lesion was located in the moderately tortuous and non-calcified vessel.A 200cm x 10cm gw fathom-14, angled tip guidewire was selected for embolization of intracranial aneurysm.During the procedure, the distal end of the guidewire was fractured when it reached the middle cerebral artery.The length of the fractured guidewire was approximately 7cm.The guidewire was simply pulled out, and the fractured guidewire was removed.The procedure was completed with another of the same guidewire.There were no patient complications as a result of this event, and the patient was stable post-procedure.

• 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: 23110020
• Report Number: 2124215-2025-66054
• Device Sequence Number: 9937311
• Product Code: DQX
• UDI-Device Identifier: 08714729801030
• UDI-Public: (01)08714729801030(17)271119(10)35319832
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: M001508110
• Device Catalogue Number: M001508110
• Device Lot Number: 0035319832
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 50 KG