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

Model Number	M001508100
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 18dec2025.It was reported that tracking difficulty occurred.During a genicular artery embolization, a 14, 200 cm x 10 cm fathom guidewire was selected for use.It was attempted to advance the microwire through the 155cm truselect microcatheter, but increased resistance was noticed.The microcatheter was removed, re-flushed, and the microwire was advanced again, but the same resistance was encountered.It was attempted to remove the microwire again, but both microcatheter and microwire started to bunch.There were no patient complications as a result of this event.However, returned device analysis revealed that the guidewire coating was peeled,.
Additional Manufacturer Narrative
The device was returned for analysis.During the inspection, it was observed that the distal tip was bent.Upon microscopic examination, it was noted that the guidewire coating was peeled.Detailed product and complaint information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24048084
• Report Number: 2124215-2026-02017
• Device Sequence Number: 15916467
• Product Code: DQX
• UDI-Device Identifier: 08714729801023
• UDI-Public: (01)08714729801023
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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: M001508100
• Device Catalogue Number: M001508100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: 155CM TRUSELECT.
• Patient Sex: Unknown