MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION? FATHOM?-16 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	M001195650
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	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that microcatheter fracture occurred.A direxion? fathom?-16 system catheter-infusion was selected for use.During the procedure, the microcatheter was introduced into the patient.However, the microcatheter fractured into several segments.The device was removed, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
G4 - premarket / 510(k) #: k142259, k163701.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, initial reporter, and product return status, but further information was unable to be obtained.If additional details become available, a supplemental report will be submitted.

• Brand Name: DIREXION? FATHOM?-16 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24292568
• Report Number: 2124215-2026-07138
• Device Sequence Number: 15785947
• Product Code: KRA
• UDI-Device Identifier: 08714729839644
• UDI-Public: (01)08714729839644(17)270521(10)36578861
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K142259
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

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: M001195650
• Device Catalogue Number: M001195650
• Device Lot Number: 0036578861
• 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: 01/13/2026
• Initial Report FDA Received Date: 02/09/2026
• Date Device Manufactured: 05/21/2025
• 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