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

Model Number	M001195650
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	01/13/2026
Type of Reportable Event	Malfunction
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.
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.
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 investigation results: device evaluated by mfr: the direxion device was returned to our post market quality assurance laboratory.The returned device consists of direxion microcatheter in 3 separate pieces as the shaft is detached from the luer and piece of the hypo tube is removed from the shaft.Visual examination reveals a nickel shaft fractured is located at the hub.Another nickel shaft fracture is located approximately 19cm from the hub.The inner lumen is stretched approximately 1cm.This concludes the product analysis.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which 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 device confirmed that the reported event 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 benefits for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause linked to device but unable to trace more specifically.
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
E.Initial reporter - updated to physician details.G4 - premarket / 510(k) #: k142259, k163701.

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 24292549
• Report Number: 2124215-2026-07135
• Device Sequence Number: 9426582
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/15/2026; 03/16/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/16/2026; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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