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

Model Number	M001195230
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	02/11/2026
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, but further information was unable to be obtained.Investigation results: 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 confirmed that the event of nickel shaft fracture 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: boston scientific concludes the most probable root cause as unable to exclude device problem due to the complaint device not returned for analysis and the reported information does not clearly indicate a cause of the reported issue.The reported event was confirmed through review of the images the site provided.It was found that the direxion microcatheter nitinol shaft did break exposing the inner lumen near the strain relief.However, it was unable to be determined what caused the nitinol of the microcatheter to break.
Event or Problem Description
It was reported that a device fracture occurred.A direxion microcatheter was selected for use.During the procedure, it was noted that the outer layer of the catheter split in the patient.The device was removed, and the procedure was completed with an alternate device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
G4: premarket / 510(k): k142259, k163701.Investigation results: upon receipt at our post market quality assurance laboratory, this direxion microcatheter device was examined visually to reveal a nickel shaft fracture located approximately 27cm from the strain relief with an associated inner shaft stretch extending approximately 31.5cm.No other issues were identified during the product analysis.Media was received in the form of an image: review of media submitted with the complaint has been thoroughly examined and evaluated to reveal a nickel shaft fracture and inner shaft stretch near the proximal end of the direxion microcatheter.Another photo was submitted displaying the device label.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 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.Conclusion: based on a thorough review of the reported complaint, boston scientific concludes the most probable root cause as cause linked to device but unable to trace more specifically.
Event or Problem Description
It was reported that a device fracture occurred.A direxion microcatheter was selected for use.During the procedure, it was noted that the outer layer of the catheter split in the patient.The device was removed, and the procedure was completed with an alternate device.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: 24546042
• Report Number: 2124215-2026-12861
• Device Sequence Number: 12178087
• Product Code: KRA
• UDI-Device Identifier: 08714729839347
• UDI-Public: (01)08714729839347(17)271218(10)38224529
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: M001195230
• Device Catalogue Number: M001195230
• Device Lot Number: 0038224529
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2025
• 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