MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM? -14; wire, guide, catheter

Model Number	M001508110
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.The patient underwent transcatheter internal iliac artery embolization for bladder hemorrhage.A 200cm x 10cm fathom-14 guidewire was selected for use.However, during the procedure, while advancing the guidewire through the microcatheter under digital subtraction angiography (dsa) guidance, the tip of the guidewire remained stationary despite multiple attempts to advance it.The guidewire and microcatheter were withdrawn together.Upon external inspection, it was noted that the guidewire tip was detached.The device was removed, and the procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.
Event or Problem Description
It was reported that tip detachment occurred.The patient underwent transcatheter internal iliac artery embolization for bladder hemorrhage.A 200cm x 10cm fathom-14 guidewire was selected for use.However, during the procedure, while advancing the guidewire through the microcatheter under digital subtraction angiography (dsa) guidance, the tip of the guidewire remained stationary despite multiple attempts to advance it.The guidewire and microcatheter were withdrawn together.Upon external inspection, it was noted that the guidewire tip was detached.The device was removed, and the procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.It was further reported that the target lesion was non-stenosed, non-tortuous, and non-calcified.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.Media review: the device was not returned.However, a photo was provided from the healthcare facility.It shows the distal tip was detached.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50400843
• Report Number: 2124215-2026-45306
• Device Sequence Number: 13054670
• Product Code: DQX
• UDI-Device Identifier: 08714729801030
• UDI-Public: (01)08714729801030(17)281118(10)38000793
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/25/2026

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: M001508110
• Device Catalogue Number: M001508110
• Device Lot Number: 0038000793
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 11/19/2025
• 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 Age: 80 YR
• Patient Sex: Female
• Patient Weight: 121 LB