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

Model Number	M001195610
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was broken.A direxion? fathom? 16 system catheter infusion was selected for use.During the procedure, resistance was encountered while withdrawing the catheter.Upon removal, it was observed that the catheter had fractured.The procedure was completed using with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the device was broken.A direxion? fathom?-16 system catheter infusion was selected for use.During the procedure, resistance was encountered while withdrawing the catheter.Upon removal, it was observed that the catheter had fractured.The procedure was completed using with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
The device was returned for analysis.A direxion microcatheter was received at the complaint investigation site (cis) for evaluation.Visual inspection showed that the device was separated into two pieces, with a break identified at the strain relief.A fracture of the nickel shaft was also observed.Inspection of the remaining portions of the device revealed no additional damage or irregularities.Product analysis confirmed the reported complaint.

• 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: 23533621
• Report Number: 2124215-2025-81164
• Device Sequence Number: 9084000
• Product Code: KRA
• UDI-Device Identifier: 08714729839606
• UDI-Public: (01)08714729839606(17)261219(10)35521435
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: M001195610
• Device Catalogue Number: M001195610
• Device Lot Number: 0035521435
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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