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

Model Number	M001195240
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4 - weight: 75 g.E1 - initial reporter facility name: (b)(6).E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k142259, k163701.
Event or Problem Description
It was reported that catheter fracture occurred.The target lesion was located in a vessel outside of the neck.A direxion microcatheter was selected for use for arteriovenous malformation.During procedure, in attempt to deploy the coil, the coil could not be advanced after repeated attempts.Upon further examination, it was found that the microcatheter was fractured and could not be advanced.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient status was stable post procedure.
Additional Manufacturer Narrative
A4: weight: 75 g.E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).G4: premarket/510(k) #: k142259, k163701.
Event or Problem Description
It was reported that catheter fracture occurred.The target lesion was located in a vessel outside of the neck.A direxion microcatheter was selected for use for arteriovenous malformation.During procedure, in attempt to deploy the coil, the coil could not be advanced after repeated attempts.Upon further examination, it was found that the microcatheter was fractured and could not be advanced.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient status was stable post procedure.It was further reported that the fracture was located in the connection between catheter and torquer.
Additional Manufacturer Narrative
A4 - weight: 75 g.E1 - initial reporter facility name: (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.Visual examination did not reveal any problems with the microcatheter.Functional testing was completed by inserting a guidewire and no issues were met when the guidewire was fully inserted.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that catheter fracture occurred.The target lesion was located in a vessel outside of the neck.A direxion microcatheter was selected for use for arteriovenous malformation.During procedure, in attempt to deploy the coil, the coil could not be advanced after repeated attempts.Upon further examination, it was found that the microcatheter was fractured and could not be advanced.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient status was stable post procedure.It was further reported that the fracture was located in the connection between catheter and torquer.

• Brand Name: DIREXION?
• 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: 22841190
• Report Number: 2124215-2025-56053
• Device Sequence Number: 15818468
• Product Code: KRA
• UDI-Device Identifier: 08714729839354
• UDI-Public: (01)08714729839354(17)261027(10)35156183
• 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
• Report Date (Section B): 10/30/2025

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: M001195240
• Device Catalogue Number: M001195240
• Device Lot Number: 0035156183
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 09/30/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/23/2025; 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2024
• 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 Age: 12 YR
• Patient Sex: Male
• Patient Weight: 75 KG