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

Model Number	M001509100
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket/510(k) #: k111485, k170636.
Event or Problem Description
It was reported that distal tip detachment occurred.A 180x25cm fathom 16.016 perph gw was used for procedure.During the procedure, the tip of the guidewire separated.The detached tip was removed by withdrawing the base of the catheter, and it remained intact within the catheter base.The tip was ultimately retrieved from the patient in two pieces.The procedure was successfully completed using an alternative device.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 guidewire was returned with the torquer device.Visual and microscopic inspection revealed that the distal tip was detached, which confirmed the reported observation.
Event or Problem Description
It was reported that distal tip detachment occurred.A 180x25cm fathom 16.016 perph gw was used for procedure.During the procedure, the tip of the guidewire separated.The detached tip was removed by withdrawing the base of the catheter, and it remained intact within the catheter base.The tip was ultimately retrieved from the patient in two pieces.The procedure was successfully completed using an alternative device.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: 22311072
• Report Number: 2124215-2025-40219
• Device Sequence Number: 12775664
• Product Code: DQX
• UDI-Device Identifier: 08714729762553
• UDI-Public: (01)08714729762553(17)280315(10)36078471
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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): 08/12/2025

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: 0036078471
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2025
• 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
• Patient Sex: Unknown