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

Model Number	M001195450
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via medwatch # (b)(4) that a device break occurred.A direxion hi-flo was selected for use.Prior to procedure, it was noted that the wire within the microcatheter was found broken.There were no patient complications as a result of this event.
Event or Problem Description
It was reported via medwatch # (b)(4) that a device break occurred.A direxion hi-flo was selected for use.Prior to procedure, it was noted that the wire within the microcatheter was found broken.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
H10: related report number added.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22874301
• Report Number: 2124215-2025-57504
• Device Sequence Number: 5689786
• Product Code: KRA
• UDI-Device Identifier: 08714729839521
• UDI-Public: (01)08714729839521(17)250914(10)32431062
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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 Expiration Date: 09/14/2025
• Device Model Number: M001195450
• Device Catalogue Number: M001195450
• Device Lot Number: 0032431062
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 09/21/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/20/2025
• Date Device Manufactured: 09/15/2023
• 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