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

Model Number	M001195500
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.A 0.027in swan tip 130cm direxion? hi-flo? microcatheter was selected for use in the liver during a transcatheter arterial chemoembolization procedure.Outside the patient, when the microcatheter was unpacked and removed from the packaging, it felt stiff and could not be advanced into the radiography catheter.The microcatheter was found to be fractured.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 in stable condition following the procedure.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k142259, k163701.Investigation results: media review: media was received in the form of an image.Review of media revealed a direxion? hi-flo? microcatheter inserted into the carrier hoop.The nickel shaft was fractured near the strain relief with an associated inner shaft stretch.Device technical analysis: the device was not returned for analysis; therefore, a technical analysis could not be performed.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? hi-flo? 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.

• Brand Name: DIREXION? HI-FLO?
• 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: 25162944
• Report Number: 2124215-2026-25887
• Device Sequence Number: 18823622
• Product Code: KRA
• UDI-Device Identifier: 08714729839576
• UDI-Public: (01)08714729839576(17)260626(10)34316947
• 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
• Report Date (Section B): 05/13/2026

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: 06/26/2026
• Device Model Number: M001195500
• Device Catalogue Number: M001195500
• Device Lot Number: 0034316947
• 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: 04/16/2026
• Initial Report FDA Received Date: 05/13/2026
• Date Device Manufactured: 06/26/2024
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 60 KG