MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION? TRANSEND?-14 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	M001195840
Medical Device Problem Codes	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	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6).G4: premarket / 510(k): k142259, k163701.
Event or Problem Description
It was reported that microcatheter fractured occurred.The target lesion was located in the gastroduodenal artery.A ngmc/transend/021/bern/1ro/130 direxion was selected for use.After unpacking, it was noted that the tail end of the microcatheter 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 phone: (b)(6).G4: premarket / 510(k): k142259, k163701.Investigation results: device evaluated by mfr: the direxion device was returned for analysis.The device was examined visually and microscopically to reveal a shaft fracture located at the strain relief and approximately 4cm from the strain relief and an inner lumen kink is located approximately 4cm from the strain relief.The reported event was confirmed.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause linked to device but unable to trace more specifically.
Event or Problem Description
It was reported that microcatheter fractured occurred.The target lesion was located in the gastroduodenal artery.A ngmc/transend/021/bern/1ro/130 direxion was selected for use.After unpacking, it was noted that the tail end of the microcatheter 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? TRANSEND?-14 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: 24332657
• Report Number: 2124215-2026-08226
• Device Sequence Number: 15889010
• Product Code: KRA
• UDI-Device Identifier: 08714729839774
• UDI-Public: (01)08714729839774(17)271031(10)37849393
• 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
• Report Date (Section B): 04/02/2026

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: M001195840
• Device Catalogue Number: M001195840
• Device Lot Number: 0037849393
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2025
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 60 KG