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

Model Number	M001508110
Medical Device Problem Codes	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	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the gw fathom periph was returned with the torquer device for analysis.Visual inspection revealed that it was detached, stretched and kinked at distal tip, moreover the proximal section was kinked.No other issues were identified with the device.
Event or Problem Description
Reportable based on device analysis completed on 26jun2025.It was reported that catheter kink occurred.A 200cm x 10cm fathom-14 guidewire was selected for use in a transarterial chemoembolization procedure.During procedure, the catheter body was kinked.The procedure was completed with another of same device.There were no patient complications as a result of this event.However, device analysis revealed that the guidewire 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: 22569975
• Report Number: 2124215-2025-48576
• Device Sequence Number: 13082172
• Product Code: DQX
• UDI-Device Identifier: 08714729801030
• UDI-Public: (01)08714729801030(17)270812(10)34621313
• 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): 07/22/2025

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: 0034621313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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: 53 YR
• Patient Sex: Male