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

Model Number	M001195440
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of cad (coronary artery disease), htn (hypertension), dm (diabetes mellitus) and cirrhosis of the liver.Procedure: cta (computed tomography angiography) of abdomen and pelvis with contrast.While injecting contrast into the patient, the hub of the catheter broke off.The catheter was flushed prior to use.No known harm to patient.Manufacturer response for catheter, continuous flush, direxion hi-flo (per site reporter) will obtain.

• 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: 17469055
• Report Number: 17469055
• Device Sequence Number: 20613352
• Product Code: KRA
• UDI-Device Identifier: 08714729839514
• UDI-Public: (01)08714729839514(17)250518(10)31651118
• 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): 07/31/2023
• Report Date (Section F): 07/31/2023

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: M001195440
• Device Lot Number: 31651118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 66 KG
• Date Report Sent to FDA: 07/31/2023