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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire tip detachment occurred.A 180 cm x 25 cm fathom?: 16 was selected for a procedure.During the procedure, however, the tip of the guidewire detached inside the patient.After retrieving the tip, another guidewire had to be used.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B3: date of event was not provided.Estimated to be the date boston scientific became aware of the event.
Event or Problem Description
It was reported that guidewire tip detachment occurred.A 180cm x 25cm fathom? -16 was selected for a procedure.During the procedure, however, the tip of the guidewire detached inside the patient.After retrieving the tip, another guidewire had to be used.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B3: date of event was not provided.Estimated to be the date boston scientific became aware of the event.Device evaluation by manufacturer: one gw fathom periph was returned for analysis.The guidewire returned kinked in different sections.The device was inspected under magnification, and it was possible to see that the distal tip is detached; however, the detach section did not return.

• 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: 23542435
• Report Number: 2124215-2025-80239
• Device Sequence Number: 18571725
• Product Code: DQX
• UDI-Device Identifier: 08714729762553
• UDI-Public: (01)08714729762553(17)280710(10)36949983
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: 0036949983
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2025
• 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