MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM 16; WIRE, GUIDE, CATHETER

Model Number	M001509100
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4-premarket / 510(k) #: k111485, k170636.
Event or Problem Description
It was reported that guidewire fracture occurred.A 180 x 25 cm fathom-16 guidewire was selected for use.During the procedure, the guidewire frayed and broke off in a patient.The wire was retrieved, there were no patient complications as a result of this event.
Additional Manufacturer Narrative
G4-premarket / 510(k) #: k111485, k170636.Device evaluated by mfr: the fathom 16 was returned for analysis.Visual and microscope inspections were performed.It was observed that the distal tip was detached, stretched and bent.No other issues were identified with the device.
Event or Problem Description
It was reported that guidewire fracture occurred.A 180x25cm fathom-16 guidewire was selected for use.During the procedure, the guidewire frayed and broke off in a patient.The wire was retrieved.There were no patient complications as a result of this event.

• Brand Name: FATHOM 16
• 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: 21791253
• Report Number: 2124215-2025-20421
• Device Sequence Number: 18350263
• Product Code: DQX
• UDI-Device Identifier: 08714729762553
• UDI-Public: (01)08714729762553(17)271021(10)35114417
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111485
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: M001509100
• Device Catalogue Number: M001509100
• Device Lot Number: 0035114417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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 Sex: Unknown