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

Model Number	M001195240
Medical Device Problem Codes	Break (1069); Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter fracture occurred.The target lesion was located in the femoral artery.A direxion microcatheter was selected for use in a femoral artery embolism.During the procedure, upon adjusting the direction of the microcatheter, the microcatheter was fractured.The procedure was completed with another of same device.There were no patient complications as a result of this event and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k142259, k163701.
Additional Manufacturer Narrative
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 the femoral artery.A direxion microcatheter was selected for use in a femoral artery embolism.During the procedure, upon adjusting the direction of the microcatheter, the microcatheter was fractured.The procedure was completed with another of same device.There were no patient complications as a result of this event and the patient was stable post procedure.It was further reported that a fracture occurred in the middle of the microcatheter.The inner cavity remained intact, with only the nickel rod was fractured and the shaping mandrel still in place inside the tip.
Event or Problem Description
It was reported that catheter fracture occurred.The target lesion was located in the femoral artery.A direxion microcatheter was selected for use in a femoral artery embolism.During the procedure, upon adjusting the direction of the microcatheter, the microcatheter was fractured.The procedure was completed with another of same device.There were no patient complications as a result of this event and the patient was stable post procedure.It was further reported that a fracture occurred in the middle of the microcatheter.The inner cavity remained intact, with only the nickel rod was fractured and the shaping mandrel still in place inside the tip.
Additional Manufacturer Narrative
E1 - initial reporter zip/post code: updated.E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k142259, k163701.H6 - device codes: updated.Device evaluated by mfr: the direxion microcatheter was returned to our post market quality assurance laboratory.During visual inspection a fracture was found on the nickel shaft 22cm from the strain relief, it was also found that there was a kink in the inner shaft where the facture is.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported complaint.

• 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: 22838934
• Report Number: 2124215-2025-56054
• Device Sequence Number: 18513072
• Product Code: KRA
• UDI-Device Identifier: 08714729839354
• UDI-Public: (01)08714729839354(17)270129(10)35736231
• 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): 11/10/2025

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: 0035736231
• 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: 08/17/2025; 10/13/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/15/2025; 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 70 KG