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

Model Number	M001508100
Medical Device Problem Codes	Fracture (1260); 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	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire fractured.A 200 cm x 10 cm fathom? -14 guidewire was selected for use.During preparation, there was no resistance, but the guidewire sheared or fractured.It appears that the guidewire may have been damaged prior to being fully removed from its plastic casing.Peeled coating was noticed.The procedure was completed successfully using another device of the same type.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
The device was returned for evaluation.Upon inspection, the guidewire was found to be unraveled, bent, stretched, and detached at the distal tip.In addition, the coating was observed to be peeled.The distal tip specifically demonstrated unraveling, bending, stretching, and detachment, with associated coating damage.Photographic evidence attached in the parent record further confirms that the guidewire was stretched, bent, and exhibited coating peel.
Event or Problem Description
It was reported that the guidewire fractured.A 200 cm x 10 cm fathom? -14 guidewire was selected for use.During preparation, there was no resistance, but the guidewire sheared or fractured.It appears that the guidewire may have been damaged prior to being fully removed from its plastic casing.Peeled coating was noticed.The procedure was completed successfully using another device of the same type.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the returned device was evaluated.Upon inspection, the guidewire was found to be unraveled, bent, stretched, and detached at the distal tip.In addition, peeling of the coating was observed.A photo provided by the site further confirms that the guidewire was stretched, bent, and exhibited areas of peeled coating.
Event or Problem Description
It was reported that the guidewire fractured.A 200 cm x 10 cm fathom? -14 guidewire was selected for use.During preparation, there was no resistance, but the guidewire sheared or fractured.It appears that the guidewire may have been damaged prior to being fully removed from its plastic casing.Peeled coating was noticed.The procedure was completed successfully using another device of the same type.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: 22613836
• Report Number: 2124215-2025-48839
• Device Sequence Number: 21223712
• Product Code: DQX
• UDI-Device Identifier: 08714729801023
• UDI-Public: (01)08714729801023(17)280411(10)36290173
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2025

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: M001508100
• Device Catalogue Number: M001508100
• Device Lot Number: 0036290173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 09/30/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/08/2025; 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2025
• 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 Sex: Unknown