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	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Early 30¿s female with history of chronic pelvic pain and pelvic varices.Procedure: left renal and ovarian venogram, embolism of left-ovarian vein and para-uterine veins, pelvic venogram superior hypogastric nerve block.During the procedure, the yellow end of the catheter malfunctioned and broke.Broken piece was outside of the body- catheter removed without known harm to patient.A new catheter used without incident.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; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 14955833
• Report Number: 14955833
• Device Sequence Number: 6905548
• Product Code: KRA
• UDI-Device Identifier: 08714729839521
• UDI-Public: (01)08714729839521(17)240310(10)29026934
• 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): 06/27/2022
• Report Date (Section F): 06/27/2022

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: M001195450
• Device Lot Number: 29026934
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 06/27/2022