MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X40CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56140
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ekos device was leaking lytic.An ekosonic endovascular device, 135x40cm was selected for use to treat a case of deep vein thrombosis.The target lesion was accessed via the left groin.After over 17 hours of ekos therapy without issue, it was observed that there was fluid leaking from the strain relief, past the catheter manifold.After the coolant rate was dropped, the leak did not subside.It was presumed that the leak was attributed to lytic.The physician elected to remove the ekos device from the patient at around 9:30 am, while still in the icu.The tpa drip was connected directly to a 65cm sheath in the mid superficial femoral artery until the patient could be taken to the catheterization lab for the scheduled recheck.At approximately 12pm, the patient was returned to the catheterization lab.There was observed to be complete resolution of the clot.No further treatment was needed, and the case was successfully completed.There were no reported patient complications.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X40CM
• 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: 18035351
• Report Number: 2124215-2023-60443
• Device Sequence Number: 15520985
• Product Code: KRA
• UDI-Device Identifier: 00858593006301
• UDI-Public: 00858593006301
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 10/30/2023

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: 03/15/2026
• Device Model Number: 500-56140
• Device Catalogue Number: 500-56140
• Device Lot Number: 8035535291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 10/30/2023
• 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
• Patient Sex: Unknown