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

Model Number	M001195300
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G1: mfr site zip/post code: t12 yk88.G4: pma/510(k) # field is k142259, k163701 - reported here as the pma # exceeded character limit for designated field.E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a fracture occurred.A direxion was selected for use in a prostate artery embolization procedure.During the procedure, the direxion fractured at the distal end.A new device was used to complete the procedure.There were no patient complications as a result of the event.
Additional Manufacturer Narrative
G1: mfr site zip/post code: t12 yk88.G4: pma/510(k) # field is k142259, k163701 - reported here as the pma # exceeded character limit for designated field.E1: initial reporter phone: (b)(6).Device history records (dhr) 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.Device technical analysis: the returned device consists of a direxion microcatheter in two pieces, where the shaft is separated from the hub.Visual examination revealed a nickel shaft fracture at the hub and the inner lumen detached from the hub.Another nickel shaft fracture is located approximately 44cm from the proximal end.The inner lumen stretch is located approximately 44cm to 48.5cm from the proximal end.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 statement: a risk review performed for the direxion device confirmed that the reported events are known events defined in the products risk management documentation.This event 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 cause linked to device but unable to trace more specifically.
Event or Problem Description
It was reported that a fracture occurred.A direxion was selected for use in a prostate artery embolization procedure.During the procedure, the direxion fractured at the distal end.A new device was used to complete the procedure.There were no patient complications as a result of the 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24323255
• Report Number: 2124215-2026-07710
• Device Sequence Number: 18654323
• Product Code: KRA
• UDI-Device Identifier: 08714729839415
• UDI-Public: (01)08714729839415(17)271023(10)37775263
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/16/2026

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: M001195300
• Device Catalogue Number: M001195300
• Device Lot Number: 0037775263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• 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