MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION? HI-FLO? FATHOM?-16 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	M001195710
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).
Event or Problem Description
It was reported that the catheter frayed.A direxion hi-flo microcatheter was selected for use in a uterine fibroid embolization procedure.The vessel was mildly calcified and tortuous.During use, the distal tip of the catheter frayed.A new direxion hi-flo microcatheter was selected for use but the same event occurred.It was exchanged for a non-bsc catheter, and the procedure was successfully completed.There were no patient complications as a result of the event.

• Brand Name: DIREXION? HI-FLO? FATHOM?-16 SYSTEM
• 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: 22968613
• Report Number: 2124215-2025-62130
• Device Sequence Number: 15767442
• Product Code: KRA
• UDI-Device Identifier: 08714729839682
• UDI-Public: (01)08714729839682(17)270114(10)35629292
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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: M001195710
• Device Catalogue Number: M001195710
• Device Lot Number: 0035629292
• 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: 08/21/2025
• Initial Report FDA Received Date: 09/04/2025
• Date Device Manufactured: 01/14/2025
• 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