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

Model Number	M001195240
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Middle-aged female with acute onset of rectal bleed.Procedure: ima (inferior mesenteric artery) angiogram and embolization of descending colon.The micro catheter hub broke/fractured during the contrast injection.Micro-catheter removed without known harm to patient.

• Brand Name: DIREXION
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 17360508
• Report Number: 17360508
• Device Sequence Number: 14972365
• Product Code: KRA
• UDI-Device Identifier: 08714729839354
• UDI-Public: (01)08714729839354(17)250417(10)311444789
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/07/2023
• Report Date (Section F): 07/07/2023

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: M001195240
• Device Lot Number: 311444789
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 61 KG
• Date Report Sent to FDA: 07/07/2023