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

Model Number	M001509100
Medical Device Problem Codes	Detachment of Device or Device Component (2907); 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	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.The patient was presented with melanoma cancer with metastasis to the liver.A 180x25cm fathom-16 guidewire was selected for use to gain access to the distal liver with a non-boston scientific microcatheter.Upon advancing, the initial trek of the wire was tortuous, requiring significant torquing.However, upon torquing, the tip of the wire was not torquing accordingly.The wire was pulled out and the distal piece was missing.The catheter was pulled out with the distal portion still intact in the catheter.New catheter and wire were used to complete the procedure.There were no patient complications as a result of this event.The only negative outcome was the loss of access and the additional time added to the case.
Additional Manufacturer Narrative
G4-premarket / 510(k) #: k111485, k170636.
Additional Manufacturer Narrative
G4-premarket / 510(k) #: k111485, k170636 device evaluated by mfr: the fathom-16 guidewire was returned for analysis.Visual and microscopic inspections revealed the guidewire was detached and peeled at the distal tip.
Event or Problem Description
It was reported that tip detachment occurred.The patient was presented with melanoma cancer with metastasis to the liver.A 180x25cm fathom-16 guidewire was selected for use to gain access to the distal liver with a non-boston scientific microcatheter.Upon advancing, the initial trek of the wire was tortuous, requiring significant torquing.However, upon torquing, the tip of the wire was not torquing accordingly.The wire was pulled out and the distal piece was missing.The catheter was pulled out with the distal portion still intact in the catheter.New catheter and wire were used to complete the procedure.There were no patient complications as a result of this event.The only negative outcome was the loss of access and the additional time added to the case.

• 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: 22212037
• Report Number: 2124215-2025-38315
• Device Sequence Number: 8619856
• Product Code: DQX
• UDI-Device Identifier: 08714729762553
• UDI-Public: (01)08714729762553(17)280219(10)35896161
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 0035896161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROGREAT CATHETER.; PROGREAT CATHETER.
• Patient Sex: Unknown