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

Model Number	M001195300
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	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter break occurred.A direxion microcatheter was selected for an embolization during the management of active bleeding.During the microcatheterization of the artery with the direxion microcatheter, the microcatheter frame broke.The radiologist cut the microcatheter to remove if and used a new microcatheter of the same model to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Investigation results: device technical analysis: the returned device consists of a direxion microcatheter in 2 pieces as the shaft is detached at midpoint.Visual examination revealed a nickel shaft fracture located approximately 22.5cm from the strain relief with an associated inner shaft stretch extending approximately 36cm from the strain relief.Microscopic examination revealed inner shaft crushed section located approximately 2.5cm from the proximal nickel shaft fracture.The remaining exposed inner shaft revealed multiple shaft kinks.Device history records 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 there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of 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 benefit 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 a catheter break occurred.A direxion microcatheter was selected for an embolization during the management of active bleeding.During the microcatheterization of the artery with the direxion microcatheter, the microcatheter frame broke.The radiologist cut the microcatheter to remove if and used a new microcatheter of the same model to complete the procedure.There were no patient complications as a result of this event.

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 24586597
• Report Number: 2124215-2026-13922
• Device Sequence Number: 5725092
• Product Code: KRA
• UDI-Device Identifier: 08714729839415
• UDI-Public: (01)08714729839415(17)260611(10)34214121
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 05/01/2026

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 Expiration Date: 06/11/2026
• Device Model Number: M001195300
• Device Catalogue Number: M001195300
• Device Lot Number: 0034214121
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown