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

Model Number	H74939605135200
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drug port was cracked and leaking.An ekos+ device was selected for use to treat a heavy arterial thrombus burden.The device was placed without issue and was intended to delivery 0.5mg of lytic therapy for 24 hours.The patient was transferred to the icu.At 9:00pm, a pool of serosanguinous fluid was observed around the catheter.Upon further inspection, it was noted that there was a leak at the drug connection to the stopcock.A crack on the catheter was observed at this location.The crack was unsuccessfully attempted to be sealed.To bypass the issue, the tpa line was connected to the coolant line to continue ekos therapy.No further issues were reported with the device.There were no reported patient complications.

• Brand Name: EKOS+
• 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; marlborough MA 01752
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18477100
• Report Number: 2124215-2023-75695
• Device Sequence Number: 6885733
• Product Code: KRA
• UDI-Device Identifier: 00191506015527
• UDI-Public: 00191506015527
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• 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): 01/09/2024

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 Model Number: H74939605135200
• Device Catalogue Number: H74939605135200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown