MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION? HI-FLO?; CATHETER, CONTINUOUS FLUSH

Model Number	M001195440
Medical Device Problem Codes	Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the direxion hi-flo was returned for analysis.Visual examination revealed nickel shaft fracture located approximately 3.5cm from the strain relief.Microscopic examination revealed the inner lumen stretched approximately 3.5cm.Puncture marks located approximately 1cm and 1mm from the distal tip.No other issues were identified with the device.
Event or Problem Description
Reportable based on device analysis completed on 25jun2025.It was reported that the microcatheter was blocked.A direxion hi-flo was selected for use in a right thoracic tumor and bronchial artery chemoembolization procedure.During procedure, the microcatheter was blocked and could not be used.The procedure was completed another of same device.There were no patient complications as a result of this event.However, device analysis revealed that the nickel shaft was fractured.

• Brand Name: DIREXION? HI-FLO?
• 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: 22568351
• Report Number: 2124215-2025-48574
• Device Sequence Number: 3915747
• Product Code: KRA
• UDI-Device Identifier: 08714729839514
• UDI-Public: (01)08714729839514(17)260926(10)34932860
• 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
• Report Date (Section B): 07/22/2025

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 Expiration Date: 09/26/2026
• Device Model Number: M001195440
• Device Catalogue Number: M001195440
• Device Lot Number: 0034932860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 62 KG