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

Model Number	M001508110
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a guidewire coating issue occurred.The procedure involved accessing a stenosed target lesion located in the intracranial region.For this purpose, a 200cm x 10cm fathom-14 guidewire was selected.During the insertion process, it was observed that the guidewire had developed creases, and its coating had flaked off.Due to these issues, the original guidewire was replaced with another device of the same type, and the procedure was successfully completed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
The device was returned for analysis and inspected in accordance with the peripheral intervention product analysis guidelines established by bsc.Upon examination, the guidewire exhibited kinking at both the distal tip and the middle section.Additionally, peeling of the coating was observed.
Event or Problem Description
It was reported that a guidewire coating issue occurred.The procedure involved accessing a stenosed target lesion located in the intracranial region.For this purpose, a 200cm x 10cm fathom-14 guidewire was selected.During the insertion process, it was observed that the guidewire had developed creases, and its coating had flaked off.Due to these issues, the original guidewire was replaced with another device of the same type, and the procedure was successfully completed.There were no patient complications as a result of this event.

• 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: 21774178
• Report Number: 2124215-2025-20402
• Device Sequence Number: 8263641
• Product Code: DQX
• UDI-Device Identifier: 08714729801030
• UDI-Public: (01)08714729801030(17)270818(10)34659546
• 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): 07/02/2025

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: 0034659546
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2024
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 56 KG