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

Model Number	80619
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that microcatheter was fractured.A direxion hi-flo was selected for use in a hepatic arterial infusion chemotherapy.The catheter was successfully placed, and patient was injected with chemotherapy drugs.During nurse's ward round, the patient complained that there was fluid flowing out of the catheter on the right side, and it was immediately checked and found that the microcatheter was kinked, 2ml of bright red blood could be seen flowing out through the microcatheter.A sterile gauze was pressed at the patient's blooding end and closed the infusion end.Upon checking the spot, it was found out that the microcatheter had cracks in many places and could not be used anymore.The physician removed the microcatheter and adjusted the infusion of chemotherapy drugs through the hepatic arterial catheter.The patient's vital signs were stable under continuous infusion on the spot and the patient was discharged with no complications.The device was disposed at the facility and will not be returned for evaluation.

• 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: 19264465
• Report Number: 2124215-2024-26232
• Device Sequence Number: 15106817
• Product Code: KRA
• UDI-Device Identifier: 08714729839484
• UDI-Public: 08714729839484
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

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: 03/27/2025
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0031318387
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• 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: 58 YR
• Patient Sex: Male