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

Model Number	M001508110
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Device evaluated by mfr: the fathom-14 was returned for analysis.The guidewire was returned; it was possible to observe that the distal tip was detached and kinked.
Event or Problem Description
Reportable based on device analysis completed on 28aug2025.It was reported that device difficult to track over wire and tip damage occurred.The target lesion was located in the abdominal cavity.A 200cm x 10cm fathom-14 was selected for use.During the procedure, it was noted that when guidewire entered the lesion.The tip was weak and could not guide.The guidewire was withdrawn, and it was noted that the tip was tortuous and deformed.There were no patient complications as a result of this event.However, returned device analysis revealed a distal tip was detached.

• 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: 22866076
• Report Number: 2124215-2025-57481
• Device Sequence Number: 15386719
• Product Code: DQX
• UDI-Device Identifier: 08714729801030
• UDI-Public: (01)08714729801030(17)271002(10)34978503
• 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
• Report Date (Section B): 08/21/2025

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: 0034978503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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: 67 YR
• Patient Sex: Male