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

Model Number	M001195840
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reported facility name: (b)(6).
Event or Problem Description
It was reported that the device fractured.A direxion? transend? 14 system was selected for use in a transarterial chemoembolization (tace) procedure.During the procedure, the microcatheter body fractured during catheter twisting.The procedure was completed using with another of the same device.There were no patient complications as a result of this event, and the patient was in stable condition following the procedure.
Event or Problem Description
It was reported that the device fractured.A direxion? transend?-14 system was selected for use in a transarterial chemoembolization (tace) procedure.During the procedure, the microcatheter body fractured during catheter twisting.The procedure was completed using with another of the same device.There were no patient complications as a result of this event, and the patient was in stable condition following the procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter phone: (b)(6).Device evaluation by manufacturer: the device was returned to the arden hills complaint investigation site (cis) for evaluation.Visual inspection identified two fractures on the nickel shaft: one located approximately 7.5 cm distal to the strain relief and another at the strain relief itself.The fractures corresponded to a kink observed on the inner shaft.Examination of the remaining components revealed no additional damage or abnormalities.Product analysis confirmed the reported issue.

• 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: 22954388
• Report Number: 2124215-2025-59677
• Device Sequence Number: 9894091
• Product Code: KRA
• UDI-Device Identifier: 08714729839774
• UDI-Public: (01)08714729839774(17)270418(10)36328664
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163701
• 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): 12/23/2025

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: 0036328664
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2025
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 65 KG