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

Model Number	M001195450
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The wire within microcatheter was found broken during prep of the catheter.The catheter was removed and replaced with no reported harm to the patient.Manufacturer response for microcatheter, 2.8fr distal od x 155cm direxion hi-flo torqueable microcatheter, bern tip, 0.02 (per site reporter).Mfg [manufacturer] notified by site.

• Brand Name: DIREXION¿ HI-FLO¿
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 22622806
• Report Number: 22622806
• Device Sequence Number: 18250043
• Product Code: KRA
• UDI-Device Identifier: 08714729839521
• UDI-Public: (01)08714729839521
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2025
• Report Date (Section F): 07/10/2025

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
• Device Model Number: M001195450
• Device Lot Number: 32431062
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/10/2025