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

Model Number	M001195500
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip fracture occurred.A direxion hi-flo microcatheter was selected for transcatheter arterial chemoembolization (tace).During the procedure, it was noted that the entire tip was fractured.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
(b)(6).G4 - premarket / 510(k) #: k142259, k163701.
Additional Manufacturer Narrative
H6 - device codes: updated from detachment of device or device component to material integrity problem.E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k142259, k163701.
Event or Problem Description
It was reported that tip fracture occurred.A direxion hi-flo microcatheter was selected for transcatheter arterial chemoembolization (tace).During the procedure, it was noted that the entire tip was fractured.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
(b)(6).G4 - premarket / 510(k) #: k142259, k163701.Device evaluated by mfr: the direxion microcatheter was returned to our post market quality assurance laboratory.During visual inspection it was found that the catheter was separated at the hub.Inspection of the remainder of the device presented no other damage or irregularities.The site provided a photo.The photo submitted revealed a complete separation of the shaft from the hub.
Event or Problem Description
It was reported that tip fracture occurred.A direxion hi-flo microcatheter was selected for transcatheter arterial chemoembolization (tace).During the procedure, it was noted that the entire tip was fractured.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k142259, k163701.Device evaluated by mfr: the direxion microcatheter was returned to our post market quality assurance laboratory.During visual inspection it was found that the catheter was separated at the hub.Inspection of the remainder of the device presented no other damage or irregularities.The site provided a photo.The photo submitted revealed a complete separation of the shaft from the hub.
Event or Problem Description
It was reported that tip fracture occurred.A direxion hi-flo microcatheter was selected for transcatheter arterial chemoembolization (tace).During the procedure, it was noted that the entire tip was fractured.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: 22778605
• Report Number: 2124215-2025-55384
• Device Sequence Number: 15788225
• Product Code: KRA
• UDI-Device Identifier: 08714729839576
• UDI-Public: (01)08714729839576(17)270328(10)36176666
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/17/2025

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: M001195500
• Device Catalogue Number: M001195500
• Device Lot Number: 0036176666
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 10/03/2025; 12/02/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/10/2025; 10/30/2025; 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 52 KG