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

Model Number	M001195300
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4 premarket / 510(k) #: k142259, k163701.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the batch/lot is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.
Event or Problem Description
It was reported that tip fracture occurred.A direxion catheter infusion was selected for use.While inspecting and shaping the tip of the device, it fractured and could no longer be used.The procedure was completed with a similar device.There was 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; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22152700
• Report Number: 2124215-2025-32980
• Device Sequence Number: 15832679
• Product Code: KRA
• UDI-Device Identifier: 08714729839415
• UDI-Public: (01)08714729839415
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2025

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: M001195300
• Device Catalogue Number: M001195300
• 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: 05/09/2025
• Initial Report FDA Received Date: 06/05/2025
• 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