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

Model Number	M001195840
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft fracture occurred.A direxion transend-14 system was selected for transcatheter arterial chemoembolization (tace) in the liver.During the procedure, the microcatheter was inserted into the blood vessel for normal operation.Upon withdrawal from the blood vessel, it was found that the front end of the microcatheter was fractured.The procedure was completed with another of same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
G4-premarket / 510(k) #: k142259, k163701.
Additional Manufacturer Narrative
G4-premarket / 510(k) #: k142259, k163701.Device evaluated by mfr: the direxion was returned for analysis.The returned device consists of the direxion as 2 pieces.Visual and microscopic examination revealed nickel shaft fracture located approximately 8.5cm from strain relief.The inner lumen was separated from the luer.Inner lumen is stretched approximately 1.5cm from the purple liner to proximal end.No damage to the remaining shaft distal to the fracture or tip.
Event or Problem Description
It was reported that shaft fracture occurred.A direxion transend-14 system was selected for transcatheter arterial chemoembolization (tace) in the liver.During the procedure, the microcatheter was inserted into the blood vessel for normal operation.Upon withdrawal from the blood vessel, it was found that the front end of the microcatheter was fractured.The procedure was completed with another of 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: 21733908
• Report Number: 2124215-2025-19344
• Device Sequence Number: 18392775
• Product Code: KRA
• UDI-Device Identifier: 08714729839774
• UDI-Public: (01)08714729839774(17)261018(10)35095032
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K1422599
• 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): 05/12/2025

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: M001195840
• Device Catalogue Number: M001195840
• Device Lot Number: 0035095032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 57 KG