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

Model Number	M001195650
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device fracture occurred.A direxion? fathom?-16 system was selected for a coiling procedure to treat an endoleak.During the procedure, however, the direxion fractured.A new direxion? fathom?-16 system was selected to complete the procedure.There were no patient complications as a result of this event, and the patient was expected to fully recover.
Event or Problem Description
It was reported that device fracture occurred.A direxion? fathom?-16 system was selected for a coiling procedure to treat an endoleak.During the procedure, however, the direxion fractured.A new direxion? fathom?-16 system was selected to complete the procedure.There were no patient complications as a result of this event, and the patient was expected to fully recover.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the returned device consists of direxion microcatheter in 2 pieces as the luer is separated from the shaft.The microcatheter was received with a coil inserted.Microscopic examination revealed a nickel shaft fracture located at the hub.The inner lumen liner is separated from the luer.The non-boston scientific coil delivery system has a kink to the pusher wire and a coil in the catheter.Device history review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the direxion? fathom?-16 system confirmed that the event of shaft fracture is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific concludes the most probable root cause as cause linked to device but unable to trace more specifically.It was reported that the direxion device was fractured.Device analysis that the direxion microcatheter broke into 2 pieces as the luer is separated from the shaft.The reported damage was confirmed, but the reported information does not clearly indicate a cause of the reported issue.

• 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: 24053468
• Report Number: 2124215-2026-02103
• Device Sequence Number: 9495013
• Product Code: KRA
• UDI-Device Identifier: 08714729839644
• UDI-Public: (01)08714729839644(17)270110(10)35597841
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 0035597841
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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