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

Model Number	M001195640
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter break occurred.A direxion? fathom?-16 system catheter infusion was selected for use.During the procedure, after the catheter was flushed, it was noted to be broken upon withdrawal.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
The device was returned for evaluation.Visual inspection identified a fracture of the nickel shaft located approximately 40 cm and 50.5 cm from the strain relief.Microscopic examination further revealed a kink in the inner lumen at approximately 40 cm from the strain relief.
Event or Problem Description
It was reported that catheter break occurred.A direxion? fathom?-16 system catheter infusion was selected for use.During the procedure, after the catheter was flushed, it was noted to be broken upon withdrawal.There were no patient complications as a result of this event.

• Brand Name: DIREXION? 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: 23728347
• Report Number: 2124215-2025-86917
• Device Sequence Number: 10231969
• Product Code: KRA
• UDI-Device Identifier: 08714729839637
• UDI-Public: (01)08714729839637(17)270410(10)36278462
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K163701
• 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,Followup
• Report Date (Section B): 02/05/2026

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: M001195640
• Device Catalogue Number: M001195640
• Device Lot Number: 0036278462
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• 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