MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOS¿ +; CATHETER, CONTINUOUS FLUSH

Model Number	H74939605106120
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
One of the cords for the ekos [ekosonic endovascular system] had a crack in it and was leaking fluid at one of the connections.We had to open a new product, take out the broken one and re-insert the new one.No harm to patient.

• Brand Name: EKOS¿ +
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 21950048
• Report Number: 21950048
• Device Sequence Number: 8802640
• Product Code: KRA
• UDI-Device Identifier: 00191506015466
• UDI-Public: (01)00191506015466
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/24/2025
• Report Date (Section F): 04/24/2025

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
• Operator of Device: Health Professional
• Device Model Number: H74939605106120
• Device Catalogue Number: H74939605106120
• Device Lot Number: 8035476002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2025
• 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 Age: 58 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/24/2025