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	11/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ekos device was leaking.An ekosonic endovascular device, 106x18cm was selected for use to treat a pulmonary embolism.When the physician attempted to flush the ekos catheter, it was observed that the hub was pulling air.It was not reported whether the physician was attempting to flush coolant or lytic.The ekos device was exchanged to resolve the issue.It was not reported at what point during ekos therapy the device exchange occurred.There were no reported patient consequences.
Event or Problem Description
It was reported that the ekos device was leaking.An ekosonic endovascular device, 106x18cm was selected for use to treat a pulmonary embolism.When the physician attempted to flush the ekos catheter, it was observed that the hub was pulling air.It was not reported whether the physician was attempting to flush coolant or lytic.The ekos device was exchanged to resolve the issue.It was not reported at what point during ekos therapy the device exchange occurred.There were no reported patient consequences.

• 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: 18258867
• Report Number: 2124215-2023-68469
• Device Sequence Number: 7691023
• Product Code: KRA
• UDI-Device Identifier: 00858593006141
• UDI-Public: 00858593006141
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 12/13/2023

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: 07/24/2026
• Device Model Number: 500-55118
• Device Catalogue Number: 500-55118
• Device Lot Number: 8035716831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2023
• 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