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

Model Number	M001195840
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket/510(k) # - k142259, k163701.
Event or Problem Description
It was reported that shaft rupture occurred.The patient underwent hepatic arterial chemoembolization.Arteriography revealed that the target vessel was tortuous.A direxion catheter-infusion was used to superselect the feeding artery of the tumor.However, during introduction, the end of the catheter ruptured outside the patient, resulting in the inability to rotate.A new microcatheter was used to complete the procedure.The patient condition following the procedure was unknown.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
The device, which consists of a direxion microcatheter, was returned for analysis.A thorough examination revealed no damage or irregularities to the microcatheter.
Event or Problem Description
It was reported that shaft rupture occurred.The patient underwent hepatic arterial chemoembolization.Arteriography revealed that the target vessel was tortuous.A direxion catheter-infusion was used to superselect the feeding artery of the tumor.However, during introduction, the end of the catheter ruptured outside the patient, resulting in the inability to rotate.A new microcatheter was used to complete the procedure.The patient condition following the procedure was unknown.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: 22151842
• Report Number: 2124215-2025-36948
• Device Sequence Number: 7849110
• Product Code: KRA
• UDI-Device Identifier: 08714729839774
• UDI-Public: (01)08714729839774(17)270109(10)35595474
• 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): 08/08/2025

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: 0035595474
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2025
• 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: 54 YR
• Patient Sex: Unknown