MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X30CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-55130
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drug luer was cracked and leaking.This 106x30cm ekosonic endovascular device was selected for use for a deep vein thrombosis popliteal procedure.The catheter was placed, and the patient was brought to the intensive care unit for treatment.At that time, lytic therapy could not be started due to a cracked and leaking drug luer.An attempt was made to repair the drug luer and run the catheter as a standard infusion catheter; however, drug continued to leak from the luer.No patient complications were reported.Additional information was requested but was not available.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X30CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20146967
• Report Number: 2124215-2024-54214
• Device Sequence Number: 20897716
• Product Code: KRA
• UDI-Device Identifier: 00858593006165
• UDI-Public: 00858593006165
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K213422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2024

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 Expiration Date: 11/23/2025
• Device Model Number: 500-55130
• Device Catalogue Number: 500-55130
• Device Lot Number: 8035343371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 09/05/2024
• Date Device Manufactured: 11/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown