MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X18CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-55118
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that both the drug and coolant luers were leaking, and as a result, the patient was returned to the catheterization lab for device exchange.An ekosonic endovascular device, 106x18cm was selected for use in a bilateral pulmonary embolism case.Approximately 90 minutes into ekos therapy, it was observed that there was fluid leaking out of the infusion catheter on channel b, where the rubber connection met the catheter, near the white hub.The physician flushed the drug and coolant luers with saline to check which luer was leaking.It was determined that both luers were leaking at the site when flushed.The physician elected to bring the patient back to the catheterization lab and exchange the ekos device for an ekos +.The patient was reported to be doing fine.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X18CM
• 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: 18675921
• Report Number: 2124215-2024-07227
• Device Sequence Number: 15258215
• Product Code: KRA
• UDI-Device Identifier: 00858593006141
• UDI-Public: 00858593006141
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2026
• Device Model Number: 500-55118
• Device Catalogue Number: 500-55118
• Device Lot Number: 8035527651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown