MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM? -14; wire, guide, catheter

Model Number	M001508100
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire fractured inside the microcatheter during insertion.A 200 cm x 10 cm fathom? -14 guidewire was selected for use in a y-90 mapping procedure.The guidewire had been shaped five to six times prior to use.While inserting the guidewire into a 2.4f non-boston scientific (bsc) microcatheter, the guidewire felt crunchy.An attempt was made to take the guidewire out of the microcatheter, but the guidewire became stuck within the microcatheter and broke apart.The guidewire fractured into two pieces; both pieces were removed.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable.

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50868761
• Report Number: 2124215-2026-50648
• Device Sequence Number: 13106373
• Product Code: DQX
• UDI-Device Identifier: 08714729801023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Device Lot Number: 0039677900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 06/26/2026
• 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