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	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).G4 - premarket / 510(k) #: k142259, k163701.
Event or Problem Description
It was reported that the front part of the microcatheter was fractured.The target lesion was located in the liver.A ngmc/single/021/bern/1ro/130 direxion microcatheter was selected for use.During the procedure, it was noted that the front part of the micro catheter 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 facility name: (b)(6).E1 - initial reporter address 1: (b)(6).G4 - premarket / 510(k) #: k142259, k163701.
Event or Problem Description
It was reported that the front part of the microcatheter was fractured.The target lesion was located in the liver.A ngmc/single/021/bern/1ro/130 direxion microcatheter was selected for use.During the procedure, it was noted that the front part of the micro catheter was fractured.The procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that it was the nickel jacket of the tip that was fractured with the inner liner still intact.The fracture occurred at 0.5cm from the hub which could never enter the patient's body.
Additional Manufacturer Narrative
E1 - (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 revealed nickel shaft fracture at the strain relief.Microscopic examination revealed inner lumen kinked and stretched approximately.5cm from the nickel shaft fracture site.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the front part of the microcatheter was fractured.The target lesion was located in the liver.A ngmc/single/021/bern/1ro/130 direxion microcatheter was selected for use.During the procedure, it was noted that the front part of the micro catheter was fractured.The procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that it was the nickel jacket of the tip that was fractured with the inner liner still intact.The fracture occurred at 0.5cm from the hub which could never enter the patient's body.

• 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: 21951684
• Report Number: 2124215-2025-25295
• Device Sequence Number: 9122287
• Product Code: KRA
• UDI-Device Identifier: 08714729839354
• UDI-Public: (01)08714729839354(17)261022(10)35123973
• 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): 06/30/2025

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: 0035123973
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 04/28/2025; 06/03/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/22/2025; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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: 47 YR
• Patient Sex: Male
• Patient Weight: 81 KG