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

Model Number	M001509100
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire fracture occurred requiring additional intervention.During a transcatheter arterial chemoembolization (tace) procedure involving the liver, a 180 cm x 25 cm fathom-16 guidewire was used for super-selection.The target vessel exhibited moderate tortuosity and no calcification.During use, the guidewire fractured within the blood vessel, separating into two pieces.The physician successfully retrieved the fractured segment using a catcher device.The procedure was completed with another of same device.The patient remained stable following the procedure, with no reported complications or injury.
Additional Manufacturer Narrative
G4: premarket / 510(k): k111485, k170636.E1: initial reporter phone: (b)(6).
Additional Manufacturer Narrative
Correction to field h6: device codes from fracture to detachment of device or device component g4: premarket / 510(k): k111485, k170636.E1: initial reporter phone: (b)(4).
Event or Problem Description
It was reported that guidewire fracture occurred requiring additional intervention.During a transcatheter arterial chemoembolization (tace) procedure involving the liver, a 180 cm x 25 cm fathom-16 guidewire was used for super-selection.The target vessel exhibited moderate tortuosity and no calcification.During use, the guidewire fractured within the blood vessel, separating into two pieces.The physician successfully retrieved the fractured segment using a catcher device.The procedure was completed with another of same device.The patient remained stable following the procedure, with no reported complications or injury.

• 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: 23486852
• Report Number: 2124215-2025-78732
• Device Sequence Number: 10488360
• Product Code: DQX
• UDI-Device Identifier: 08714729762553
• UDI-Public: (01)08714729762553(17)270624(10)34303926
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001509100
• Device Catalogue Number: M001509100
• Device Lot Number: 0034303926
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 11/27/2025
• Date Device Manufactured: 06/24/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 52 KG