MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION?; CATHETER, CONTINUOUS FLUSH

Model Number	M001195340
Medical Device Problem Codes	Fracture (1260); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter phone: (b)(6).G4: premarket/510(k) #: k142259, k163701.
Event or Problem Description
It was reported that the device fractured.The target lesion was located in the liver.A direxion microcatheter was selected for transcatheter arterial chemoembolization (tace).However, during coil advancing, a fracture occurred at the connection point of the microcatheter's distal end.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.
Event or Problem Description
It was reported that the device fractured.The target lesion was located in the liver.A direxion microcatheter was selected for transcatheter arterial chemoembolization (tace).However, during coil advancing, a fracture occurred at the connection point of the microcatheter's distal end.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.It was further reported that the rotation at the end fractured.No fractured device was inside the patient because it was completely removed.
Additional Manufacturer Narrative
B5 - describe event or problem section updated with additional information.(b)(6).G4 - premarket / 510(k) #: k142259, k163701.

• Brand Name: DIREXION?
• 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: 23817174
• Report Number: 2124215-2025-91055
• Device Sequence Number: 13114071
• Product Code: KRA
• UDI-Device Identifier: 08714729839453
• UDI-Public: (01)08714729839453(17)270320(10)36116251
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: M001195340
• Device Catalogue Number: M001195340
• Device Lot Number: 0036116251
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/27/2026
• Date Device Manufactured: 03/20/2025
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 65 KG