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

Model Number	M001195240
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	04/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Hospital.
Event or Problem Description
It was reported that catheter fracture occurred.The target lesion was located in the moderately tortuous and mildly calcified liver.A direxion microcatheter was selected for use in transarterial embolization.During the procedure, the part of the metal catheter body that connected to the end of the twist-control head was fractured.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 catheter fracture occurred.The target lesion was located in the moderately tortuous and mildly calcified liver.A direxion microcatheter was selected for use in transarterial embolization.During the procedure, the part of the metal catheter body that connected to the end of the twist-control head was fractured.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).G4 - premarket / 510(k) #: k142259, k163701 device evaluated by mfr: the device was returned for evaluation.Microscopic examination revealed nickel shaft kink and inner lumen kink located approximately 126.5cm from the strain relief.Wire insertion test failed due to inserted guidewire stuck.No other issues were identified with the device.

• 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: 21930530
• Report Number: 2124215-2025-26470
• Device Sequence Number: 13033293
• Product Code: KRA
• UDI-Device Identifier: 08714729839354
• UDI-Public: (01)08714729839354(17)261022(10)35123973
• 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): 07/11/2025

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: M001195240
• Device Catalogue Number: M001195240
• Device Lot Number: 0035123973
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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: 73 KG